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Quality of Life in Caregivers of Hospitalized Older Patients With Cancer

Sponsor
City of Hope Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01866969
Collaborator
National Cancer Institute (NCI) (NIH)
211
Enrollment
1
Location
1
Arm
11
Duration (Months)
19.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies quality of life in caregivers of hospitalized older patients with cancer.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer.
SECONDARY OBJECTIVES:

  1. Determine characteristics of informal caregivers of older adults with cancer admitted to hospital.

  2. Determine type and amount of care informal caregivers provide for older adults with cancer admitted to hospital.

  3. Determine quality of life in informal caregivers of older adults with cancer admitted to hospital.

  4. Identify caregiver needs, both informational and resource related. V. Explore the association between re-admission to the hospital within 30 days and caregiver burden.

  5. Explore whether feedback of information attained from the assessment of the caregiver influences services implemented by the health care team.

  6. Determine reasons for non-participation.

OUTLINE:

Caregivers complete a questionnaire about their sociodemographics, physical health, social supports, social activity, mental health and caregiver burden. They will also provide an assessment of the person they care for.

Study Design

Study Type:
Interventional
Actual Enrollment :
211 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Physical, Emotional and Social Stressors and Their Impact on Quality of Life of Caregivers of Hospitalized Older Adults With Cancer
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (quality of life questionnaire)

Caregivers complete a self-administered questionnaire about factors associated with increased caregiver burden and decreased quality of life.

Other: questionnaire administration
Ancillary studies

Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Caregiver burden and caregiver quality of life as measured by the Caregiver Quality of Life-Cancer Index [Up to 1 year]

      Univariate analyses will be performed to test differences in the Caregiver Quality of Life-Cancer Index (CQOLC) total score and score of each domain (burden, distinctiveness, positive adaption, and financial concern) across categorical variables (analysis of variance [ANOVA]), and simple linear regression will be used to test association of CQOLC total score with continuous and categorical variables.

    Eligibility Criteria

    Criteria

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

    • PATIENT: Age >= 65 years old

    • PATIENT: Diagnosis of cancer (solid or hematologic malignancy)

    • PATIENT: Be able to provide informed consent

    • PATIENT: Unplanned admission to hospital

    • CAREGIVER: Primary caregiver (person who provides all of the majority of the unpaid care for the care recipient)

    • CAREGIVER: Be able to provide informed consent

    Exclusion Criteria:

    • PATIENT: Planned admission to hospital for treatment (chemotherapy, transplant)

    • CAREGIVER: Not fluent in English (because not all questionnaires have been validated in other languages)

    • CAREGIVER: Paid and trained to care for the patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Arti Hurria, MD, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01866969
    Other Study ID Numbers:
    • 13158
    • NCI-2013-01068
    • 13158
    First Posted:
    Jun 3, 2013
    Last Update Posted:
    Jul 27, 2020
    Last Verified:
    Jun 1, 2015

    Study Results

    No Results Posted as of Jul 27, 2020