Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT07061652

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-04-09

162

Participants Needed

3

Research Sites

47 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

H

Humana Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking caregivers
  • Ability to provide written or verbal informed consent
  • Willing and able to comply with study procedures
  • Age 18 years or older at consent
  • Informal (unpaid) caregiver of an adult with stage II-IV cancer and diabetes
  • English-speaking patients
  • Ability to provide informed consent
  • Patients age 18 years or older at consent
  • Patient's caregiver enrolled in the study
  • Patient diagnosed with stage II-IV solid tumor or any hematologic malignancy
  • Patient receiving active cancer treatments excluding hormonal therapy
  • Patient has diabetes requiring ongoing management
Not Eligible

You will not qualify if you...

  • Caregivers unable to complete self-report instruments due to illiteracy, neurologic illness, or inability to speak/read English
  • Caregivers with co-morbid diseases that prohibit participation
  • Caregivers who participated in the intervention development phase
  • Patients unable to complete self-report instruments due to illiteracy, neurologic illness, or inability to speak/read English
  • Patients with co-morbid diseases that prohibit participation
  • Patients whose caregivers do not enroll or withdraw consent

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

2

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

3

University of Vermont Cancer Center

Burlington, Vermont, United States, 05401

Actively Recruiting

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Research Team

A

Ashley Hanson

CONTACT

C

Caroline Martin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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