Family Caregivers in Underserved Populations Providing Complex Cancer Care

NCT ID: NCT05213078

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-03-09

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (teaching intervention, questionnaire)

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

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive teaching intervention

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive teaching intervention

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Quality of Life Assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

City of Hope Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Betty Ferrell

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2020-11090

Identifier Type: REGISTRY

Identifier Source: secondary_id

20137

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20137

Identifier Type: -

Identifier Source: org_study_id

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