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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: Eco-mapping tool; Behavioral: Caregiver-coach study visits

• Registration Number: NCT05828927
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-12
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-25
• Study Start: 2023-05-15
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caregiver of subject with cancer	Caregiver-coach study visits	Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.
Caregiver of subject with cancer	Eco-mapping tool	Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.

Primary Outcome Measures

Name	Time	Method
Study feasibility - caregiver enrollment	8 weeks	Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.
Study feasibility - Caregiver intervention engagement	8 weeks	Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.

Secondary Outcome Measures

Name	Time	Method
Intervention acceptability-quantitative	4 weeks, 8 weeks	Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.
Caregiver self-efficacy	Baseline, 4 weeks, 8 weeks	Caregiver self-efficacy will be measured using the Coping Self-Efficacy Scale (CSES).; The CSES is a 26-item measure of one's confidence in performing coping behaviour when facing life challenges. It measures the use of problem-focused coping, receiving of social support and stopping unpleasant emotions and thoughts. Scores range from not at all confident=0 to very confident=100. A score of 0 means 'extremely low self efficacy' and a score of 100 means 'extremely high self efficacy'.
Intervention acceptability-qualitative	4 weeks, 8 weeks	Intervention acceptability will be measured using the Acceptability of the Intervention Measure (AIM) survey scores.; AIM is a survey questionnaire that includes 4 questions. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse-coded.

Trial Locations

Locations (1)

UNC Lineberger; 🇺🇸 Chapel Hill, North Carolina, United States