Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study

The complexity of cancer patients' symptoms and health problems constitutes considerable distress and burden for patients and their family caregivers. To help them manage the illness effectively, there is a need to better understand the complexity of symptoms and symptom clusters in patients and caregivers. Therefore, the purpose of this research is to explore a set of important fundamental research questions to advance the scientific knowledge of cancer patients' and caregivers' symptoms, symptom clusters and health-related quality of life. The investigators will follow 500 cancer patients and their caregivers with repeated measures over 6 months to assess their symptoms, symptom clusters, and quality of life over time. Caregiver burden will also be examined in the caregivers.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Caregiver Burden Depression Dyssomnias Fatigue Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Sleeping Problems Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sykehuset Østfold, Fredrikstad, Norway

About this study

The specific aims of the study, where we will follow 500 cancer patients and their caregivers with repeated measures over 6 months, are to:

Explore cancer patients' symptoms, symptom clusters and symptom changes over time; and identify subgroups of patients with different symptom clusters.
Identify genomic markers for the different patient subgroups.
Explore symptoms, symptom clusters and burden in caregivers of cancer patients.
Explore relationships between patients' and caregivers' symptoms, symptom clusters, quality of life and caregiver burden.

Patients will be asked to complete questionnaires to collect demographic characteristics and self-reported medical history information, a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status and quality of life. The patients' medical record will be reviewed for disease and treatment information.

The caregivers will also be asked to complete questionnaires about a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status, quality of life and caregiver burden.

Data Analyses will be done to identify symptom clusters of the different symptoms, and to identify patient subgroups based on their symptom experience and quality of life. Variations in symptom clusters and quality of life over time will also be evaluated. Genetic analyses will also be done in the patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients are:

diagnosed with breast, colon, head and neck or ovarian cancer
receiving active treatment for their cancer (chemo- or radiation therapy)
above 18 years of age
able to read / write /speak Norwegian.

Inclusion criteria

for caregivers:

above 18 years
read and speak Norwegian
and written informed consent.

Exclusion criteria

patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.

Treatment and study plan

Primary outcomes

Physical functioning and quality of life

Time frame: 5 to 8 times during 6 months

Secondary outcomes

Symptoms will be measured both in patients and caregivers. Caregiver burden will be measured in the caregivers. A blood sample for genetic testing will be taken from the patients once

Time frame: 5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

University of California, San Francisco

Registry information

Official study title

Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Oct 9, 2008
Registry last updated: Aug 7, 2018

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.

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