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Trial Title:
enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
NCT ID:
NCT05828927
Condition:
Cancer
Conditions: Keywords:
social support
rural
caregivers
coaching
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Eco-mapping tool
Description:
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
Arm group label:
Caregiver of subject with cancer
Intervention type:
Behavioral
Intervention name:
Caregiver-coach study visits
Description:
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.
Arm group label:
Caregiver of subject with cancer
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.
Criteria for eligibility:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jesse Kovacs
Phone:
919-962-5356
Email:
encompasscarolina@unc.edu
Start date:
May 15, 2023
Completion date:
July 1, 2025
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
The Duke Endowment
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05828927
