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CompletedNCT03069105Updated Nov 13, 2020

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

An observational study in Caregivers and Cancer, sponsored by Saint John's Cancer Institute. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Saint John's Cancer Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
49
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Caregivers
  • Cancer

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In context

Caregiver Burden

422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.

This study's enrollment of 49 is below the median of 90 across 80 observational studies indexed under Caregiver Burden.

Browse Caregiver Burden studies →

Lead sponsor

Saint John's Cancer Institute is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • Professional or paid caregivers
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
49 participants (actual)
Patient registry
No

Groups and 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.

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    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 researchers measure

Primary outcomes

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

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

    Time frame: 1 year

Secondary outcomes

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

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

    Time frame: 1 year

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Study locations

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

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. PubMed 28189161 ↗
  • 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. PubMed 27921222 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03069105
Lead sponsor
Saint John's Cancer Institute
Responsible party
Marlon Garzo Saria (Assistant Professor, Saint John's Cancer Institute) — Principal investigator
First posted
Mar 3, 2017
Start date
Feb 23, 2017
Primary completion
Apr 28, 2020
Completion
Apr 28, 2020
Last update
Nov 13, 2020

Study contacts

Santosh Kesari, MD PhD
study chair · Saint John's Cancer Institute
Marlon G Saria, PhD RN FAAN
principal investigator · John Wayne Cancer Institute at Providence Saint John's Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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