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

NCT05828927 | Completed DMC

• 1 other identifier: LCCC2242
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Keywords

social support; rural; caregivers; coaching

Outcome Measures

Primary Outcomes (2)

• Study feasibility - caregiver enrollment

  Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.

  8 weeks

• Study feasibility - Caregiver intervention engagement

  Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.

  8 weeks

Secondary Outcomes (3)

• Intervention acceptability-qualitative

  4 weeks, 8 weeks

• Intervention acceptability-quantitative

  4 weeks, 8 weeks

• Caregiver self-efficacy

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Caregiver of subject with cancer

OTHER

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

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

Subject with Cancer

NO INTERVENTION

Subjects is with cancer and receive care from caregivers.

Interventions

Eco-mapping tool 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 of subject with cancer

Caregiver-coach study visits 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.

Caregiver of subject with cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking.
• Ability to provide written or electronic informed consent to participate in the study.
• Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
• 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).
• Their identified caregiver is enrolled in the study
• English-speaking.
• Ability to provide written or electronic informed consent to participate in the study.
• Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
• 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
• \. Live in a rural area according to the USDA's Rural/Urban Commuting Area (RUCA) score of \>4.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• The Duke Endowment: collaborator

Study Sites (1)

UNC Lineberger

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 39234997 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Erin E Kent, PhD, MS

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: May 15, 2023
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

US (1)