Quality of Life in Caregivers of Hospitalized Older Patients With Cancer

July 23, 2020 updated by: City of Hope Medical Center

Physical, Emotional and Social Stressors and Their Impact on Quality of Life of Caregivers of Hospitalized Older Adults With Cancer

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

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. Identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer.

SECONDARY OBJECTIVES:

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

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

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

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

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

VII. 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 Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Ancillary studies
Ancillary studies
Other Names:
  • quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver burden and caregiver quality of life as measured by the Caregiver Quality of Life-Cancer Index
Time Frame: 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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

June 3, 2013

Study Record Updates

Last Update Posted (Actual)

July 27, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 13158 (Other Identifier: City of Hope Medical Center)
  • NCI-2013-01068 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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