Recruiting

enCompass Humana

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07061652

Conditions

Cancer

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Survey

the resource booklet from the American Cancer Society

Study Details

Brief summary:

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.

Conditions

Cancer

Diabetes

Study ID

NCT07061652

Start date

Jul 3, 2025

Status verified date

Jul, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Inclusion Criteria for Caregivers

  • English-speaking.
  • Ability to provide written or verbal informed consent to participate in the study;
  • Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;
  • Be at least 18 years of age at the time of consent; and
  • Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.

Inclusion Criteria for patients

  • English-speaking
  • Ability to provide informed consent.
  • Be at least 18 years of age at the time of consent; and
  • Their identified caregiver is enrolled in the study
  • Diagnoses: (must have cancer and diabetes)
  • Have a cancer diagnosis for which they are being actively treated at one of the study sites
  • Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy
  • Receiving active cancer treatment s, not including hormonal therapy
  • Concurrent history of diabetes with need for ongoing management

Exclusion Criteria:

Exclusion Criteria for Caregivers

  • Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
  • Existence of another co-morbid disease other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;
  • Participation in the intervention development phase of this intervention

Exclusion Criteria for patients

  • Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
  • Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
  • Their caregiver does not enroll in the study or withdraws consent

Study Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: caregivers

Caregivers of patients with cancer and comorbid diabetes will receive the intervention, enCompass contains two components: (1) an web-based eco-mapping tool that encourages the cognitive process of identifying, organizing, and visualizing a person's social network, and (2) a manualized, one-to-one 8-week coaching intervention to develop problem-solving skills for specific support needs.

Caregivers will also receive a resource booklet from the American Cancer Society.

active comparator: caregiver

Caregivers of patients with cancer and comorbid diabetes will not receive the intervention.

Interventions

Survey

Participants will receive up to eight coaching sessions with a caregiver coach and resource materials and access to an online tool designed to help caregivers find resources.

the resource booklet from the American Cancer Society

The caregiver will receive the resource booklet from the American Cancer Society.

Primary outcome measure

  • Acceptability of the Intervention Measure (AIM) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Margaret Byrne, PhD

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Principal Investigator:

Erin E Kent, PhD

University of Vermont Cancer Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Principal Investigator:

Maija Reblin, PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 10, 2026

Last verified

Jul, 2026

Keywords

  • support application
  • caregivers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-08-10.