Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study
|ClinicalTrials.gov Identifier: NCT00769301|
Recruitment Status : Unknown
Verified June 2011 by Oslo University Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 9, 2008
Last Update Posted : June 30, 2011
|Condition or disease|
|Cancer Pain Fatigue Depression Sleeping Problems|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2014|
Not hospitalized cancer patients under active treatment
Caregivers of these cancer patients
- Physical functioning and quality of life [ Time Frame: 5 to 8 times during 6 months ]
- 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. ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769301
|Fredrikstad, Norway, 1603|
|Oslo University Hopsital, Rikshospitalet|
|Oslo, Norway, 0027|
|Oslo, Norway, 0027|
|Principal Investigator:||Tone Rustøen, PhD||Oslo University Hospital|