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

August 5, 2018 updated by: Tone Rustøen, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Fredrikstad, Norway, 1603
        • Sykehuset Østfold
      • Oslo, Norway, 0027
        • Rikshospitalet
      • Oslo, Norway, 0027
        • Oslo University Hopsital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Not hospitalized cancer patients under active treatment
2
Caregivers of these cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical functioning and quality of life
Time Frame: 5 to 8 times during 6 months
5 to 8 times during 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Tone Rustøen, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 5, 2018

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 154-08158d

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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