enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
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
🗓️ Study Start (Actual) 15 May 2023
🗓️ Primary Completion (Estimated) 1 July 2025
✅ Study Completion (Estimated) 1 July 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chapel Hill, North Carolina, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 April 2023
  • First Submitted that Met QC Criteria 12 April 2023
  • First Posted 25 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024