BC Cancer
Vancouver, British Columbia, V5Z 4E6, Canada
NCT Number: NCT07255001
The goal of this clinical trial is to measure hand grip strength in adults with pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:
* Is it feasible to measure hand grip strength as part of a clinic visit? * Are changes in hand grip strength related to changes in body composition? * Is hand grip strength related to a person's well-being? * Is hand grip strength related to how a tumour responds to treatment?
Participants will squeeze a device with their hand to measure their hand grip strength and complete questionnaires about their well-being when they are seen in clinic for their regular medical care for PDAC.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Vancouver, British Columbia, V5Z 4E6, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Squeeze a dynamometer with one hand to measure hand grip strength.
Time frame: From the date anti-cancer therapy is initiated until the 6-month follow-up assessment.
The percentage of participants with hand grip strength (HGS) test results at 6 months from treatment start date. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: At the time of the baseline assessment for the study.
The percentage of participants with hand grip strength (HGS) test results at study baseline. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the 3-month follow-up assessment.
The percentage of participants with hand grip strength (HGS) test results at 3 months from treatment start date. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the 9-month follow-up assessment.
The percentage of participants with hand grip strength (HGS) test results at 9 months from treatment start date. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the 12-month follow-up assessment.
The percentage of participants with hand grip strength (HGS) test results at 12 months from treatment start date. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The percentage of participants at each timepoint that meet the criteria for sarcopenia using the established definitions determined by CT image alone, namely the sex- and BMI-specific cut-off points developed by Caan et al. (2017).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The percentage of participants at each timepoint that meet the criteria for sarcopenia using the definition of the Sarcopenia Definitions and Outcomes Consortium (SDOC) (Bhasin et al. 2020).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The percentage of participants at each timepoint that meet the criteria for sarcopenia using the definition by the European Working Group on Sarcopenia in Older Adults (EWGSOP2) (Cruz-Jentoft et al. 2019), which is supported by the Asian Working Group for Sarcopenia (Chen et al. 2019), and the Australian and New Zealand Society for Sarcopenia and Frailty Research (Zanker et al. 2023a, Zanker et al. 2023b).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in skeletal muscle index (SMI). Hand grip strength is measured in kilograms with a hand-held dynamometer. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in skeletal muscle density (SMD). Hand grip strength is measured in kilograms with a hand-held dynamometer. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in skeletal muscle gauge (SMG). Hand grip strength is measured in kilograms with a hand-held dynamometer. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in visceral adipose tissue (VAT). Hand grip strength is measured in kilograms with a hand-held dynamometer. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in subcutaneous adipose tissue (SAT). Hand grip strength is measured in kilograms with a hand-held dynamometer. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in intermuscular adipose tissue (IMAT). Hand grip strength is measured in kilograms with a hand-held dynamometer. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the date of clinical progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 26 months.
The change in hand grip strength (HGS) for each unit of increase in progression-free survival (PFS). Hand grip strength is measured in kilograms with a hand-held dynamometer. Progression-free survival is the length of time from the first dose of treatment until the date of clinical progression.
Time frame: From the date anti-cancer therapy is initiated until the date of death or end of study, whichever comes first, assessed up to 26 months.
The change in hand grip strength (HGS) for each unit of increase in overall survival (OS). Hand grip strength is measured in kilograms with a hand-held dynamometer. Overall survival is the length of time from the initiation of treatment that participants survive.
Time frame: From the date of the baseline assessment scan until the date of clinical progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 26 months.
The change in hand grip strength (HGS) for each unit of increase in objective response rate (ORR). Hand grip strength is measured in kilograms with a hand-held dynamometer. Objective response rate is the proportion of participants who have a complete or partial response to treatment.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The difference in the amount of hand grip strength (HGS) between participants receiving different treatment regimens. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in tumour stage as defined by the American Joint Committee on Cancer (AJCC). Hand grip strength is measured in kilograms with a hand-held dynamometer. Tumour stage describes the extent of cancer growth and spread.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in hand grip strength (HGS) for each unit of increase in tumour grade as defined by a four-tier grading system. Hand grip strength is measured in kilograms with a hand-held dynamometer. Tumour grade describes the appearance of cancer cells and their expected growth rate.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The difference in the amount of hand grip strength (HGS) between participants with different sites of metastasis. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in hand grip strength (HGS). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in hand grip strength (HGS). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in hand grip strength (HGS). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Hand grip strength is measured in kilograms with a hand-held dynamometer.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle index (SMI). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle index (SMI). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle index (SMI). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Skeletal muscle index estimates overall muscle mass by dividing skeletal muscle area (SMA) or skeletal muscle mass (SMM) by height squared. SMI is measured in cm^2/m^2 and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle density (SMD). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle density (SMD). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle density (SMD). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Skeletal muscle density measures muscle composition, which includes the amount of fat and non-fat tissue within the muscle. SMD is measured in Hausefield Units (HU) and is calculated from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in skeletal muscle gauge (SMG). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle gauge (SMG). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in skeletal muscle gauge (SMG). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Skeletal muscle gauge is a measure of both skeletal muscle quantity and quality. SMG is calculated as the product of skeletal muscle index (SMI) and skeletal muscle density (SMD) and so is indirectly calculated from CT imaging of the third lumbar vertebra (L3). SMG is measured in Hausefield Units (HU)*cm^2/m^2.
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in visceral adipose tissue (VAT). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in visceral adipose tissue (VAT). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in visceral adipose tissue (VAT). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Visceral adipose tissue is fat that is stored deep within the abdominal cavity and surrounds abdominal organs. VAT assesses the volume of fat in the body. VAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in subcutaneous adipose tissue (SAT). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Subcutaneous adipose tissue is the layer of fat located directly beneath the skin, between the dermis and muscles. SAT assesses fat distribution in the body. SAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the global health status from the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The global health status measure (QL2) ranges in score from 0 to 100 with higher scores indicating a higher quality of life. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The physical functioning scale (PF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in role functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The role functioning scale (RF2) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Role functioning measures a person's ability to participate in daily life. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in emotional functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The emotional functioning scale (EF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in cognitive functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The cognitive functioning scale (CF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in social functioning, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The social functioning scale (SF) ranges from 0 to 100 with higher scores indicating a higher/healthy level of functioning. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in fatigue, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for fatigue (FA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in nausea and vomiting, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for nausea and vomiting (NV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in pain, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for pain (PA) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dyspnoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of dyspnoea (DY) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in insomnia, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of insomnia (SL) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in appetite loss, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of appetite loss (AP) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in constipation, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of constipation (CO) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in diarrhoea, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of diarrhoea (DI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in financial difficulties, as measured by the EORTC QLQ-C30 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom item of financial difficulties (FI) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in food aversion, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for food aversion (AV) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating and weight loss worry, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for eating and weight loss worry (EW) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in eating difficulties, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for eating difficulties (EAT) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in loss of control, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for loss of control (LC) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in physical decline, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The symptom scale for physical decline (PHY) ranges from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in dry mouth, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The single item measure of dry mouth (DM) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in indigestion/heartburn, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The single item measure of indigestion/heartburn (IND) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in forcing self to eat, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The single item measure of forcing self to eat (FOR) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in a participant's perception of receiving inadequate information about their weight loss from their care team, as measured by the EORTC QLQ-CAX24 questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). The single item measure of receiving inadequate information about weight loss (INF) ranges in score from 0 to 100 with higher scores indicating a high level of symptomatology or problems. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the Index Value from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). In Canada, the Index Value ranges from -0.148 to 0.949 with larger and more positive numbers indicating better health. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.
The change in quality of life, as measured by the visual analogue scale (EQ-VAS) from the EuroQol EQ-5D-5L questionnaire, for each unit of increase in intermuscular adipose tissue (IMAT). EQ-VAS ranges from 0 to 100 with larger scores indicating better health. Intermuscular adipose tissue is fat that is located between muscle groups and underneath the deep fascia surrounding them. IMAT assesses the accumulation of fat in the body. IMAT is measured in cm^2 from CT imaging of the third lumbar vertebra (L3).
Contact information is provided by the study sponsor or research team.
British Columbia Cancer Agency
Other
Monitoring Physical Function Changes in Patients With Pancreatic Ductal Adenocarcinoma: Potential for Better Understanding of Treatment Trajectory and Survival
Acronym: PanFit
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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