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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01866969
Other study ID # 13158
Secondary ID NCI-2013-0106813
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date May 2014

Study information

Verified date June 2015
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 211
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire administration
Ancillary studies
Procedure:
quality-of-life assessment
Ancillary studies

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver burden and caregiver quality of life as measured by the Caregiver Quality of Life-Cancer Index 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
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