UMC Utrecht
Utrecht, Netherlands
Location status: Recruiting
Location contact
Evelyn Monninkhof, PhD
CONTACT
Kristel van Asselt, PhD, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07110753
A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. This study aims to assess the effect of a combined lifestyle intervention for patients with cancer on quality of life.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Utrecht, Netherlands
Location status: Recruiting
Evelyn Monninkhof, PhD
CONTACT
Kristel van Asselt, PhD, MD
PRINCIPAL_INVESTIGATOR
A growing number of people are living with the (long-term) consequences of cancer and its treatment, which can negatively affect their quality of life. The aim of this study is to assess the effect of a combined lifestyle intervention for patients with cancer, who suffer from the consequences of cancer and its treatment, on quality of life.
The GLINK study is a pragmatic randomized controlled trial with two study arms: an intervention (n=122)- and a control arm (n=122).
The investigators will recruit 244 cancer patients who have a reduced quality of life. Participants will be either within five years post-primary treatment OR have advanced cancer (stage IV) with a prolonged life expectancy. Patients in the intervention arm will be offered a combined lifestyle intervention guided by a lifestyle coach or oncology physiotherapist and oncology nurse. The intervention consists of an intensive intervention phase of 6 months and a maintenance phase of another 6 months. The control patients will receive four online group sessions with a lifestyle coach and all educational materials after the intervention period of 6 months.
The primary endpoint is quality of life. Secondary endpoints include Positive Health and lifestyle, various lifestyle changes and body measurements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The combined lifestyle intervention focuses on various lifestyle components, including nutrition, physical activity, sleep, stress and sense of purpose, and is structured around the process of behaviour change. It is delivered by a lifestyle coach in collaboration with an oncology nurse.
The control group receives 4 online group sessions from a lifestyle coach and all educational materials after 6 months of intervention
Time frame: Measured at 0, 6 and 12 months
Summary score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This questionnaire consists of five functioning scales (physical, emotional, role, cognitive and social functioning), three symptom scales (fatigue, nausea & vomiting) and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-C30 summary score ranges from 0 to 100, with higher scores indicating better health-related quality of life. This summary score is calculated as the mean of all scale scores (excluding global QoL and financial difficulties).
Time frame: Measured at 0, 6 and 12 months
Separate functioning and symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). This questionnaire consists of five functioning scales (physical, emotional, role, cognitive and social functioning), three symptom scales (fatigue, nausea & vomiting, and pain) and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scale and item scores range from 0 to 100. Higher scores on the summary score and function scales indicate a better quality of life. Higher scores on the symptom scales mean more symptoms.
Time frame: Measured at 0, 6 and 12 months
Assessed with the Multidimensional Fatigue Inventory (MFI). The MFI is a 20-item questionnaire assessing five dimensions of fatigue: general, physical and mental fatigue, reduced activity, and reduced motivation. Each dimension has 4 items, and each item is scored on a 5-point Likert scale (1 to 5).The resulting scale scores for each dimension range from 4 to 20. Higher scores indicate higher levels of fatigue.
Time frame: Measured at 0, 6 and 12 months
Assessed with the Sleep Hygiene Index (SHI). The SHI is a questionnaire consisting of 12 items that assess sleep-related behaviors. The total score is the sum of all item responses, ranging from 0 to 52, with higher scores indicating worse sleep hygiene.
Time frame: Measured at 0, 6 and 12 months
Assessed with the 17-item Positive Health measurement tool, based on the Positive Health dialogue tool, which is widely used in the Netherlands. This tool measures six factors: physical fitness, mental functions, future perspectives, contentment, social relations, and health management. Items are scored on an 11-point scale ranging from 0 (totally disagree) to 10 (totally agree). For each factor, an average score can be calculated, with higher scores indicating better perceived Positive Health within that factor.
Time frame: Measured at 0 and 6 months
Height (in centimeters) will be measured in light clothing without shoes using standardized procedures described in study SOPs.
Time frame: Measured at 0 and 6 months
Weight (in kilograms) measured in light clothing without shoes using standardized procedures described in study SOPS
Time frame: Measured at 0 and 6 months
Waist circumference (in centimeters) will be measured in light clothing without shoes using standardized procedures described in study SOPs.
Time frame: Measured at 0 and 6 months
To assess body composition (fat mass and fat free mass), a whole body bio impedance analysis will be performed at baseline and 6 months follow-up. Patients are measured in a lying position. Raw (i.e., reactance, resistance, and phase angle) or summary (fat (free) mass in kg) bioimpedance data are registered and for raw data estimates fat mass and fat-free mass are obtained using the Kyle equation.
Time frame: Measured at 0, 6 and 12 months
Assessed by the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). This questionnaire contains questions on commuting activities, leisure-time and sports activities, household activities, and activities at work. For each activity, participants report the number of days per week, the average duration per day (in minutes), and the perceived intensity (light, moderate, or vigorous). The outcomes are expressed in minutes of physical activity per week. Higher scores indicate a higher level of physical activity.
Time frame: Measured at 0 and 6 months. The device will be worn for nine consecutive days, on the right mid-thigh, attached with adhesive tape.
Assessed by the ActivPAL activity tracker (PAL technologies). The is small device, which has shown to reliable measure and distinguish between sitting time, standing time and stepping time.
Time frame: Measured at 0, 6 and 12 months
Dietary related to cancer risk will be assessed: intake of fruit and vegetables, red and processed meat, and alcohol. These will be measured using items adapted from the Gezondheidsenquête CBS 2023 questionnaire, which is based on the Richtlijnen Goede Voeding 2015. Additionally, the use of nutritional supplements will be assessed.
Time frame: Measured at 0, 6 and 12 months
Pack years (smoking duration * amount of cigartettes) will be assessed with a self-developed questionnaire.
Time frame: Measured at 0, 6 and 12 months
Smoking status (yes/no) will be assessed with a self-developed questionnaire.
Time frame: Measured at 0, 6 and 12 months
The EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) is used to measure health in five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, using 5 levels of severity. The patients' EQ-5D-5L health states are converted into utility values using the Dutch tariff, after which they are used to calculate quality adjusted life years (QALYs).
Time frame: Measured at 0, 6 and 12 months
Assessed by a modified version of the iMTA Medical Cost Questionnaire (iMCQ)
Time frame: Measured at 0, 6 and 12 months
Assesed by the Productivity Cost Questionnaire (iPCQ)
Time frame: Measured at 0, 6 and 12 months
Assessed by the iMTA Valuation of Informal Care Questionnaire (iVCQ)
Time frame: Measured at 0, 6 and 12 months
General health literacy will be measured with the Dutch Short Health Literacy Scale (HLS-EU-Q16). This questionnaire consists of three subscales: health care, disease prevention and health promotion. The B1-level translated Dutch version will be used. It consists of 16 items, each rated on a 4-point Likert scale ranging from 1 (very difficult) to 4 (very easy). Responses are dichotomized (1-2 = 0, 3-4 = 1) and summed into a total score ranging from 0 to 16, with higher scores indicating higher perceived health literacy.
Contact information is provided by the study sponsor or research team.
Anna Manshanden, MSc
CONTACT
Evelyn Monninkhof, PhD
CONTACT
UMC Utrecht
Other
The Effect of a Combined Lifestyle Intervention for Patients With Cancer on Quality of Life: the Randomized GLINK Study
Acronym: GLINK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT05350761
Cancer, Environment
Bethesda, Maryland, United States
View Trial DetailsNCT07729969
Cancer, Cognition Disorders
Bilbao, Bizkaia, Spain
View Trial DetailsNCT05415007
Cancer, Neoplasms
San Francisco, California, United States
View Trial DetailsNCT07654998
Behavior, Behavioral Symptoms
Simav, Kütahya, Turkey (Türkiye)
View Trial Details