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CompletedNCT01866969Updated Jul 27, 2020

Quality of Life in Caregivers of Hospitalized Older Patients With Cancer

An interventional study of questionnaire administration and quality-of-life assessment in Hematopoietic/Lymphoid Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
211
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hematopoietic/Lymphoid Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
03

In context

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
211 participants (actual)

Study arms

  • 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 · Procedure: quality-of-life assessment

Interventions

  • Otherquestionnaire administration

    Ancillary studies

  • Procedurequality-of-life assessment

    Ancillary studies

    Also known as: quality of life assessment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 1 year

07

Study locations

1 site
  • City of Hope Medical Center
    Duarte, California 91010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01866969
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 3, 2013
Start date
Jun 2013
Primary completion
May 2014
Completion
May 2014
Last update
Jul 27, 2020

Study contacts

Arti Hurria, MD
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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