- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866969
Quality of Life in Caregivers of Hospitalized Older Patients With Cancer
Physical, Emotional and Social Stressors and Their Impact on Quality of Life of Caregivers of Hospitalized Older Adults With Cancer
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Ancillary studies
Ancillary studies
Other Names:
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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
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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.
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Up to 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arti Hurria, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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