Symptom Clusters in Cancer Patients & Their Caregivers- a Longitudinal

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00769301
Study type	Observational
Source	Oslo University Hospital
Contact
Status	Completed
Phase
Start date	November 2008
Completion date	December 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms