- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03069105
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
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
-
-
California
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center
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Mission Hills, California, United States, 91345
- Providence Holy Cross Medical Center
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Santa Monica, California, United States, 90404
- John Wayne Cancer Institute at Providence Saint John's Health Center
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Washington
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Redmond, Washington, United States, 98052
- EndBrainCancer Initiative/Chris Elliott Fund
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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.
|
Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.
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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
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
- Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
- Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
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.
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