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Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes

Study acronym: enCompass
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 2026 → Nov 1, 2026
See other at-risk trials from UNC Lineberger Comprehensive Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment closed, study ongoing Show 6 more changesShow less
    • Final enrollment: 118 participants (planned 162)
    • Primary completion date changed from estimate of Nov 1, 2026 to Sep 16, 2026
    • Study completion moved earlier from May 1, 2027 to Jan 27, 2027
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 7 of 8 entries
    • Site details revised at 3 of 3 sites
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Minor Primary completion pushed from Jun 2026 to Nov 1, 2026
    • Study completion pushed from Jun 2026 to May 1, 2027
    v5
  4. Minor Site details revised at 2 of 3 sitesv4
  5. Minor Study sites: 1 to 3v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program. Caregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers. Caregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs. Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.
Trial Details
NCT Number NCT07061652
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators: Humana Foundation
Conditions
(from sponsor)
Cancer, Diabetes
Related terms Diabetes Mellitus, Neoplasms
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov