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NCT05213078 Clinical Trial

Family Caregivers in Underserved Populations Providing Complex Cancer Care

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:
Family Caregivers in Underserved Populations Providing Complex Cancer Care

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05213078
Other study ID # 20137
Secondary ID NCI-2020-1109020
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date March 9, 2022

Study information
Verified date January 2024
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date March 9, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Educational Intervention
Receive teaching intervention
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
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 Change in Family caregiver distress scale 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
Primary Change in Quality of life (QOL) scale 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
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