Family Caregivers in Underserved Populations Providing Complex Cancer Care

January 2, 2024 updated by: City of Hope Medical Center
This clinical trial develops and tests a model of family caregiver education focused on the role of underserved family caregivers as providers of complex care in the home. Cancer patients have symptoms from their cancer or treatment and are then supported by family caregivers at home with tasks requiring technical skill. Family caregivers are often asked to provide complex care whether it involves decisions about managing symptoms or providing technical care for ports/pumps, tubes, or devices. Family caregivers often are not given enough information on how to provide care for patients at home needing complex care. The results from this study may help researchers refine and improve the intervention for caregivers through future research for caregivers on a much larger scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Develop methods of assessing and supporting family caregiving skills in providing complex care.

II. Develop family caregiver (FCG) teaching materials and methods of instruction to enhance skills preparedness.

III. Pilot test the intervention in a cohort of underserved FCGs.

OUTLINE:

Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.

Study Type

Interventional

Enrollment (Actual)

48

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

  • United States
    • 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

Description

Inclusion Criteria:

  • PATIENT: Diagnosis of any stage lung or gynecologic (gyn) cancer
  • PATIENT: Read and understand English
  • PATIENT: Requires either complex physical care or complex decision making regarding symptoms
  • PATIENT: Age 18 years or older
  • FCG: Designated by the patient as their caregiver
  • FCG: Read and understand English
  • FCG: Age 18 years or older
  • FCG: Providing complex care and/or complex decision-making

Exclusion Criteria:

  • Inability to read and understand English

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 (teaching intervention, questionnaire)
Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Educational Intervention
Receive teaching intervention
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Family caregiver distress scale
Time Frame: up to 7 weeks
Descriptive statistics will be used to summarize the distress scale. Analysis of variance (ANOVA) will be used to compare scores at the three points of baseline, 3 weeks, and 7 weeks.
up to 7 weeks
Change in Quality of life (QOL) scale
Time Frame: Up to 7 weeks
Descriptive statistics will be used to summarize the Caregiver QOL scale. ANOVA will be used to compare scores at the three points of baseline, 3 weeks, and 7 weeks.
Up to 7 weeks

Collaborators and Investigators

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

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Betty Ferrell, 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 (Actual)

July 15, 2020

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

December 10, 2020

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20137 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2020-11090 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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