Clinical trial NCT00769301: Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study
Official title: Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Pain
Fatigue
Depression
Sleeping Problems
Keywords: Symptoms
pain
fatigue
depression
sleeplessness
genetic markers
caregiver burden.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2008-10-09
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 cancer outpatients (125 with breast cancer and 125 with head and neck cancer receiving radiation therapy and 125 ovarian cancer patients and 125 colon cancer patients receiving chemotherapy)

and their caregivers

Brief summary: 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.

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

1. Explore cancer patients' symptoms, symptom clusters and symptom changes over time; and identify subgroups of patients with different symptom clusters.
2. Identify genomic markers for the different patient subgroups.
3. Explore symptoms, symptom clusters and burden in caregivers of cancer patients.
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical functioning and quality of life
timeFrame: 5 to 8 times during 6 months
Secondary outcomes:
measure: 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
timeFrame: 5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Sykehuset Østfold
city: Oslo
country: Norway
facility: Oslo University Hopsital, Rikshospitalet
city: Oslo
country: Norway
facility: Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Tone Rustøen, PhD
role: PRINCIPAL_INVESTIGATOR
References: