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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828927
• Other study ID #: LCCC2242
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Jesse Kovacs
• Phone: 919-962-5356
• Email: encompasscarolina[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

7. 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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• 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
• 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.

Locations

Country	Name	City	State
United States	UNC Lineberger	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	The Duke Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Intervention acceptability-qualitative	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.	4 weeks, 8 weeks
Secondary	Intervention acceptability-quantitative	Intervention acceptability will be evaluated using thematic analysis of post-intervention semi-structured interviews.	4 weeks, 8 weeks
Secondary	Caregiver self-efficacy	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'.	Baseline, 4 weeks, 8 weeks