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Clinical Trials/NCT05213078
NCT05213078
Completed
N/A

Family Caregivers in Underserved Populations Providing Complex Cancer Care

City of Hope Medical Center1 site in 1 country48 target enrollmentJuly 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignant Female Reproductive System Neoplasm
Sponsor
City of Hope Medical Center
Enrollment
48
Locations
1
Primary Endpoint
Change in Quality of life (QOL) scale
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
March 9, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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