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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769301
• Other study ID #: 154-08158d
• Status: Completed
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Depression
• Fatigue
• Pain
• Sleeping Problems

Locations

Country	Name	City	State
Norway	Sykehuset Østfold	Fredrikstad
Norway	Oslo University Hopsital, Rikshospitalet	Oslo
Norway	Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of California, San Francisco

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functioning and quality of life		5 to 8 times during 6 months
Secondary	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		5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.