enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Eco-mapping tool; Behavioral: Caregiver-coach study visits

Study type: Interventional

Funder types: Other

Identifiers

NCT05828927

LCCC2242

Details and patient eligibility

About

This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Inclusion criteria for caregivers In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. English-speaking.
2. Ability to provide written or electronic informed consent to participate in the study.
3. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
4. Age ≥ 18 years at the time of consent. Identify as an informal (unpaid) caregiver for a rural-dwelling adult with a stage II-IV solid tumor or any hematologic malignancy in active treatment (see eligibility criteria for patients).

Inclusion criteria for subjects with cancer In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

1. Their identified caregiver is enrolled in the study

2. English-speaking.

3. Ability to provide written or electronic informed consent to participate in the study.

4. Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.

5. Age ≥ 18 years at the time of consent. Have a diagnosis of stage II-IV solid tumor or any hematologic malignancy receiving active treatment s, not including hormonal therapy

6. Live in a rural area according to the USDA's Rural/Urban Commuting Area (RUCA) score of >4.

Exclusion Criteria

Exclusion criteria for caregivers

1. Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
2. Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
3. Participation in the intervention development phase of this intervention.

Exclusion criteria for subjects with cancer

1. Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
2. Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
3. Their caregiver does not enroll in the study or withdraws consent

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Caregiver of subject with cancer

Other group

Description:

Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.

Treatment:

Behavioral: Caregiver-coach study visits

Behavioral: Eco-mapping tool

Subject with Cancer

No Intervention group

Description:

Subjects is with cancer and receive care from caregivers.