Family Caregivers in Underserved Populations Providing Complex Cancer Care

NCT05213078 — Not applicable, Completed, 48 participants, City of Hope Medical Center

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Registry	NCT05213078
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	48 (Actual)
Sponsor	City of Hope Medical Center (Other); collaborators: National Cancer Institute (NCI)
Conditions	Malignant Female Reproductive System Neoplasm, Stage 0 Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Interventions	Educational Intervention, Quality-of-Life Assessment, Questionnaire Administration (Other)
Dates	start 2020-07-15, primary completion 2022-03-09, completion 2022-03-09, first posted 2022-01-28, last updated 2024-01-05
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Supportive Care (teaching intervention, questionnaire)	Experimental	Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration	Participants attend 2 teaching sessions with a research nurse. Participants also complete questionnaires at baseline, 3, and 7 weeks.

Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Receive teaching intervention
Quality-of-Life Assessment (Other), also known as Quality of Life Assessment: Ancillary studies
Questionnaire Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

Change in Family caregiver distress scale [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.
Change in Quality of life (QOL) scale [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
City of Hope Medical Center	Duarte, California	United States

+Investigators

Betty Ferrell, Principal investigator, City of Hope Medical Center

+Funding

NIH grants: P30CA033572