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

• Sponsor: Saint John's Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03069105
• Collaborator: (none)
• Enrollment: 49
• Locations: 4
• Actual Duration (Months): 38.1
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers; Cancer	Other: Questionnaire

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 Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients
• Actual Study Start Date: Feb 23, 2017
• Actual Primary Completion Date: Apr 28, 2020
• Actual Study Completion Date: Apr 28, 2020

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)] [1 year]

   Relation between caregiver burden subscale scores and caregiver resilience, social support, and coping

Secondary Outcome Measures

1. Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)] [1 year]

   Relation between caregiver anxiety and depression score and caregiver resilience, social support, and coping

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Saint Joseph Medical Center	Burbank	California	United States	91505
2	Providence Holy Cross Medical Center	Mission Hills	California	United States	91345
3	John Wayne Cancer Institute at Providence Saint John's Health Center	Santa Monica	California	United States	90404
4	EndBrainCancer Initiative/Chris Elliott Fund	Redmond	Washington	United States	98052

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.

• Responsible Party: Marlon Garzo Saria, Assistant Professor, Saint John's Cancer Institute
• ClinicalTrials.gov Identifier: NCT03069105
• Other Study ID Numbers: JWCI-16-1201
• First Posted: Mar 3, 2017
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Caregiver Burden

Study Results

No Results Posted as of Nov 13, 2020