NCT03069105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

3.2 years

First QC Date

February 23, 2017

Last Update Submit

November 10, 2020

Conditions

CaregiversCancer

Outcome Measures

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

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (1)

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

QuestionnaireOTHER

Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.

Family caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Professional or paid caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Providence Saint Joseph Medical Center

Burbank, California, 91505, United States

Location

Providence Holy Cross Medical Center

Mission Hills, California, 91345, United States

Location

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

EndBrainCancer Initiative/Chris Elliott Fund

Redmond, Washington, 98052, United States

Location

Related Publications (2)

  • 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.

    PMID: 28189161BACKGROUND

  • 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.

    PMID: 27921222BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Santosh Kesari, MD PhD

    Saint John's Cancer Institute

    STUDY CHAIR

  • Marlon G Saria, PhD RN FAAN

    John Wayne Cancer Institute at Providence Saint John's Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 3, 2017

Study Start

February 23, 2017

Primary Completion

April 28, 2020

Study Completion

April 28, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)