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

Conditions

• Cancer
• Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Accepted

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

Study Details

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.

Key Dates

Start date

Jul 3, 2025

Status verified

Apr 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

162 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

• Ashley Hanson
  984-888-9244
  [email protected]
• Caroline Martin
  919-962-5368
  [email protected]

Locations (3)

Find similar trials in Tampa, FL

Related Studies

• Personalized Environment and Genes Study
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Chapel Hill, North Carolina
• Study of the Effect of Innate on the Inflammatory Response to Endotoxin
  Recruiting · National Institute of Environmental Health Sciences (NIEHS) · Research Triangle Park, North Carolina
• Caris Biorepository Research Protocol
  Recruiting · Caris Science, Inc. · Mobile, Alabama
• Registry Study for Proton Therapy Clinical Outcomes and Long-Term Follow-up
  Recruiting · Center for Biomedical Research, LLC · Jacksonville, Florida