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

NCT ID: NCT05828927

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-06-24

Brief Summary

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Caregiver of subject with cancer

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

Group Type: OTHER

Eco-mapping tool

Intervention Type: BEHAVIORAL

The web application allows caregivers to visually identify and organize their existing social network (family, friends, community of worship, and others) to assist with their support needs, tailored to their context. For each of the six support social support domains (in-home, informational, communication, financial, emotional and spiritual, transportation (e.g., emotional, informational, practical), the enCompass web application prompts the individual to identify members of their network. After completing each domain, caregivers are presented with a visual social support

Caregiver-coach study visits

Intervention Type: BEHAVIORAL

Caregivers engage in up to 8 manualized, telephone/videoconference visits with a trained caregiver coach. The caregiver coach uses the study manual and interview guide to provide support for caregiver support-seeking and problem-solving.

Subject with Cancer

Subjects is with cancer and receive care from caregivers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Eco-mapping tool

The web application allows caregivers to visually identify and organize their existing social network (family, friends, community of worship, and others) to assist with their support needs, tailored to their context. For each of the six support social support domains (in-home, informational, communication, financial, emotional and spiritual, transportation (e.g., emotional, informational, practical), the enCompass web application prompts the individual to identify members of their network. After completing each domain, caregivers are presented with a visual social support

Intervention Type: BEHAVIORAL

Caregiver-coach study visits

Caregivers engage in up to 8 manualized, telephone/videoconference visits with a trained caregiver coach. The caregiver coach uses the study manual and interview guide to provide support for caregiver support-seeking and problem-solving.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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).

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

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

Exclusion Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Duke Endowment

OTHER

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin E Kent, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Health Policy and Management Gillings School of Global Public Health

Locations

UNC Lineberger

Chapel Hill, North Carolina, United States

Countries

United States

References

Kent EE, Tan KR, Nakamura ZM, Kovacs J, Gellin M, Deal A, Park EM, Reblin M. Building on and tailoring to: Adapting a cancer caregiver psychoeducational intervention for rural settings. Cancer Med. 2024 Sep;13(17):e70187. doi: 10.1002/cam4.70187.

Reference Type: DERIVED

PMID: 39234997 (View on PubMed)

Other Identifiers

LCCC2242

Identifier Type: -

Identifier Source: org_study_id