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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00769301
First received: October 8, 2008
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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.


Condition
Cancer
Pain
Fatigue
Depression
Sleeping Problems

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Physical functioning and quality of life [ Time Frame: 5 to 8 times during 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA analyses for genotyping subgroups of patients based on their experience with pain, fatigue, sleep disturbance and depression will test the hypothesis that gene polymorphisms within the selected candidate genes will exhibit significant differences in frequency distribution among the different patient subgroups that are identified through cluster analysis.


Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Not hospitalized cancer patients under active treatment
2
Caregivers of these cancer patients

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769301

Locations
Norway
Sykehuset Østfold
Fredrikstad, Norway, 1603
Rikshospitalet
Oslo, Norway, 0027
Oslo University Hopsital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of California, San Francisco
Investigators
Principal Investigator: Tone Rustøen, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Tone Rustøen, PhD, Rikshospitalet
ClinicalTrials.gov Identifier: NCT00769301     History of Changes
Other Study ID Numbers: 154-08158d
Study First Received: October 8, 2008
Last Updated: June 29, 2011
Health Authority: Norway: Data Protection Authority
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Symptoms
pain
fatigue
depression
sleeplessness
genetic markers
caregiver burden.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Fatigue
Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014