Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes
NCT ID: NCT07061652
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
162 participants
INTERVENTIONAL
2025-07-03
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Survey
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.
caregiver
Caregivers of patients with cancer and comorbid diabetes will not receive the intervention.
the resource booklet from the American Cancer Society
The caregiver will receive the resource booklet from the American Cancer Society.
Interventions
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Survey
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
The caregiver will receive the resource booklet from the American Cancer Society.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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Humana Foundation
UNKNOWN
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Erin E Kent, PhD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Ashley Hanson
Role: primary
Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2453
Identifier Type: -
Identifier Source: org_study_id