RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-03
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07061652

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking.
  2. * Ability to provide written or verbal informed consent to participate in the study;
  3. * Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;
  4. * Be at least 18 years of age at the time of consent; and
  5. * Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.
  6. * English-speaking
  7. * Ability to provide informed consent.
  8. * Be at least 18 years of age at the time of consent; and
  9. * Their identified caregiver is enrolled in the study
  10. * Diagnoses: (must have cancer and diabetes)
  11. * Have a cancer diagnosis for which they are being actively treated at one of the study sites
  12. * Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy
  13. * Receiving active cancer treatment s, not including hormonal therapy
  14. * Concurrent history of diabetes with need for ongoing management
  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 other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;
  3. * Participation in the intervention development phase of this intervention
  4. * Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
  5. * Existence of other co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
  6. * Their caregiver does not enroll in the study or withdraws consent

Contacts and Locations

Study Contact

Ashley Hanson
CONTACT
984-888-9244
Ashley_Hanson@med.unc.edu
Caroline Martin
CONTACT
919-962-5368
Caroline_Martin@med.unc.edu

Principal Investigator

Erin E Kent, PhD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Erin E Kent, PhD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

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

Study Start Date2025-07-03
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-07-03
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • support application
  • caregivers

Additional Relevant MeSH Terms

  • Cancer
  • Diabetes