Coaching and navigation to support family caregivers of adults with cancer and diabetes
Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes
This randomized feasibility trial tests whether the enCompass Humana coaching and navigation program plus resource materials helps unpaid adult caregivers of people who have both cancer and diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 3 sites (Tampa, Florida and 2 other locations) |
| Trial ID | NCT07061652 on ClinicalTrials.gov |
What this trial studies
The enCompass Humana program is a pilot-tested coaching and navigation intervention designed to strengthen social support for unpaid caregivers of adults who have both cancer and diabetes. In a randomized feasibility design, caregivers at three cancer centers will be offered coaching/navigation plus the American Cancer Society resource booklet and complete surveys to measure feasibility, acceptability, and preliminary effects. The intervention aims to reduce implementation barriers, tailor support to underserved and rural caregivers, and limit heavy clinical staff involvement. Results will inform whether the approach can be scaled and disseminated more broadly.
Who should consider this trial
Good fit: Ideal participants are English-speaking unpaid caregivers aged 18 or older who care for an adult with stage II–IV cancer (solid tumor or hematologic malignancy) who is receiving active cancer treatment and also has diabetes, and who can provide consent and participate in study activities.
Not a fit: People unlikely to receive benefit include non-English-speaking caregivers, paid professional caregivers, caregivers of patients not receiving active cancer treatment or without concurrent diabetes, and those unable to access the participating study sites.
Why it matters
Potential benefit: If successful, the program could increase practical and emotional support for caregivers, reduce caregiver burden, and improve coordination of care for patients with cancer and diabetes.
How similar studies have performed: Previous pilot coaching and navigation programs for cancer caregivers have shown modest improvements in caregiver support and well-being, but standardized, scalable models specifically for caregivers of patients with both cancer and diabetes are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tampa, Florida and 2 other locations
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
- University of Vermont Cancer Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Erin E Kent, PhD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Ashley Hanson
- Email: Ashley_Hanson@med.unc.edu
- Phone: 984-888-9244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.