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

NCT07061652 | Recruiting DMC

• 1 other identifier: LCCC2453
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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

Diabetes; Cancer

Keywords

support application; caregivers

Outcome Measures

Primary Outcomes (1)

• Acceptability of the Intervention Measure (AIM)

  The AIM is a 4-item, 5-point Likert scale that measures intervention acceptability. The scale measures each statement from 1, "Completely disagree," to 5, "Completely agree." Scale items are averaged to produce a mean score. The AIM takes approximately 2 minutes to complete by caregivers.

  8 weeks

Secondary Outcomes (8)

• Coping Self-Efficacy Scale (CSES)

  Baseline, 8 weeks, 6 months

• Zarit Burden Assessment - Revised

  Baseline, 8 weeks, 6 months

• Duke-UNC Functional Support Questionnaire (FSSQ)

  Baseline, 8 weeks, 6 months

• Hospital Anxiety and Depression Scale (HADS) - Caregivers

  Baseline, 8 weeks, 6 months

• Exit interview for Acceptability

  6 months

Study Arms (2)

caregivers

EXPERIMENTAL

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.

Behavioral: Survey

caregiver

ACTIVE COMPARATOR

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

Other: the resource booklet from the American Cancer Society

Interventions

Survey BEHAVIORAL

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.

caregivers

the resource booklet from the American Cancer Society OTHER

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

caregiver

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Humana Foundation: collaborator

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

RECRUITING

University of Vermont Cancer Center

Burlington, Vermont, 05401, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Neoplasms; Diabetes Mellitus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Erin E Kent, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Hanson

CONTACT

984-888-9244; Ashley_Hanson@med.unc.edu

Caroline Martin

CONTACT

919-962-5368; Caroline_Martin@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 11, 2025
• Study Start: July 3, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)