NCT01866969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 27, 2020

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

May 29, 2013

Last Update Submit

July 23, 2020

Conditions

Outcome Measures

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.

    Up to 1 year

Study Arms (1)

Supportive care (quality of life questionnaire)

EXPERIMENTAL

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

Other: questionnaire administrationProcedure: quality-of-life assessment

Interventions

Ancillary studies

Supportive care (quality of life questionnaire)

Ancillary studies

Also known as: quality of life assessment
Supportive care (quality of life questionnaire)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Arti Hurria, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 3, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 27, 2020

Record last verified: 2015-06

Locations