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

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ClinicalTrials.gov Identifier: NCT03069105
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Marlon Garzo Saria, John Wayne Cancer Institute

Tracking Information
First Submitted Date February 23, 2017
First Posted Date March 3, 2017
Last Update Posted Date November 13, 2020
Actual Study Start Date February 23, 2017
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Caregivers
  • Cancer
Intervention Other: Questionnaire
Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.
Study Groups/Cohorts 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.
Intervention: Other: Questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 10, 2020)
49
Original Estimated Enrollment
 (submitted: February 27, 2017)
122
Actual Study Completion Date April 28, 2020
Actual Primary Completion Date April 28, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03069105
Other Study ID Numbers JWCI-16-1201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marlon Garzo Saria, John Wayne Cancer Institute
Study Sponsor John Wayne Cancer Institute
Collaborators Not Provided
Investigators
Study Chair: Santosh Kesari, MD PhD John Wayne Cancer Institute
Principal Investigator: Marlon G Saria, PhD RN FAAN John Wayne Cancer Institute at Providence Saint John's Health Center
PRS Account John Wayne Cancer Institute
Verification Date November 2020