Clinical trial NCT03069105: An Exploratory Study of Caregiver Burden Among Family Caregivers of Patients With Cancer
Official title: An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregivers
Cancer
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Caregiver Burden Score [Caregiver Reaction Assessment (CRA)]
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Anxiety and Depression Score [Hospital Anxiety and Depression Scale (HADS)]
timeFrame: 1 year
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Providence Saint Joseph Medical Center
state: California
city: Mission Hills
country: United States
facility: Providence Holy Cross Medical Center
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
city: Redmond
country: United States
facility: EndBrainCancer Initiative/Chris Elliott Fund
state: Washington
Study officials:
affiliation: Saint John's Cancer Institute
name: Santosh Kesari, MD PhD
role: STUDY_CHAIR
affiliation: John Wayne Cancer Institute at Providence Saint John's Health Center
name: Marlon G Saria, PhD RN FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.