An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer

November 10, 2020 updated by: Marlon Garzo Saria, Saint John's Cancer Institute

An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients

This study will look at caregiver burden and the coping behavior of caregivers of patients with cancer. Through this study, the investigators will identify the relationship between cognitive dysfunction (measured as a proxy rating by the caregiver), resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to explore caregiver burden and the coping behavior of caregivers of patients with cancer. It has been documented that non-professional caregivers and long-term care providers to patients with cancer receive little preparation, information, or support to perform their vital role. Through this study, the investigators will identify the relationship between cognitive dysfunction, resilience, social support, cognitive appraisal, coping behavior, and caregiver burden, anxiety, and depression among family caregivers of patients with cancer. The findings of this study will direct future intervention studies to reduce caregiver burden and improve outcomes for the many individuals caring for family members with cancer.

Study Type

Observational

Enrollment (Actual)

49

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

  • United States
    • California
      • Burbank, California, United States, 91505
        • Providence Saint Joseph Medical Center
      • Mission Hills, California, United States, 91345
        • Providence Holy Cross Medical Center
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute at Providence Saint John's Health Center
    • Washington
      • Redmond, Washington, United States, 98052
        • EndBrainCancer Initiative/Chris Elliott Fund

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

The sample for this study will consist of caregivers of persons with cancer. A convenience sampling will be used to enroll eligible caregivers.

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Self-identified primary caregiver of patients with cancer
  • Co-residence with the patient
  • Providing a minimum of 4 hours of direct care for at least 3 days per week
  • Able to speak, read, and understand English
  • Willing to participate in completion of surveys

Exclusion Criteria:

  • Professional or paid caregivers

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Family caregivers
The sample for this study will consist of caregivers of patients with cancer. Eligible subjects who agrees to participate in the research study and sign the consent form will participate by completing paper and pencil or electronic questionnaires.
Other: Questionnaire
Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)]
Time Frame: 1 year
Relation between caregiver burden subscale scores and caregiver resilience, social support, and coping
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)]
Time Frame: 1 year
Relation between caregiver anxiety and depression score and caregiver resilience, social support, and coping
1 year

Collaborators and Investigators

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

Sponsor

Saint John's Cancer Institute

Investigators

  • Study Chair: Santosh Kesari, MD PhD, Saint John's Cancer Institute
  • Principal Investigator: Marlon G Saria, PhD RN FAAN, John Wayne Cancer Institute at Providence Saint John's Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 23, 2017

Primary Completion (Actual)

April 28, 2020

Study Completion (Actual)

April 28, 2020

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWCI-16-1201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe