Clinical trial NCT05828927: enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
Official title: enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: social support
rural
caregivers
coaching
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
First posted: 2023-04-25
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Study feasibility - caregiver enrollment
timeFrame: 8 weeks
measure: Study feasibility - Caregiver intervention engagement
timeFrame: 8 weeks
Secondary outcomes:
measure: Intervention acceptability-qualitative
timeFrame: 4 weeks, 8 weeks
measure: Intervention acceptability-quantitative
timeFrame: 4 weeks, 8 weeks
measure: Caregiver self-efficacy
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger
state: North Carolina
Study officials:
affiliation: Department of Health Policy and Management Gillings School of Global Public Health
name: Erin E Kent, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: