Support Program for Caregivers of Patients with Cancer and Diabetes

(enCompass Trial)

Recruiting at 2 trial locations

Overseen By Caroline Martin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Illiteracy, Neurologic illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests enCompass Humana, a program designed to support caregivers of patients with both cancer and diabetes. The goal is to determine if this intervention, which includes online tools and one-on-one coaching, can enhance caregivers' confidence and coping skills while reducing loneliness. Caregivers who may be suitable are those who informally care for an adult with stage II-IV cancer and diabetes and speak English. The trial aims to address unmet needs such as emotional support and guidance on self-care. As an unphased trial, it offers caregivers a unique opportunity to access innovative support tools and personalized coaching.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on social support for caregivers, so it's unlikely that medication changes are required.

What prior data suggests that the enCompass Humana program is safe for caregivers?

Research has shown that enCompass Humana is a social support program for caregivers of individuals with cancer and diabetes. The program includes an online tool to help caregivers understand their social connections and an eight-week coaching program to enhance problem-solving skills.

As a support program rather than a medical treatment, it poses no risk of physical harm. Early data suggest that the program may boost caregivers' confidence and reduce anxiety and depression in patients. It aims to enhance coping skills and lessen feelings of loneliness among caregivers.

Because this program is neither a drug nor a medical procedure, the risk of negative effects is very low. Its primary goal is to offer support and guidance, potentially benefiting caregivers without any known side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the enCompass Humana program because it offers a fresh approach to supporting caregivers of patients with cancer and diabetes. Unlike traditional support methods that may solely provide educational materials or group support, enCompass combines a web-based eco-mapping tool with personalized coaching. This tool helps caregivers visualize and organize their social networks, while the coaching component focuses on developing problem-solving skills tailored to their specific needs. This dual approach is designed to empower caregivers by enhancing their social support and equipping them with practical skills, potentially leading to better outcomes for both the caregivers and patients.

What evidence suggests that the enCompass Humana program is effective for supporting caregivers of patients with cancer and diabetes?

Research has shown that the enCompass Humana program, which participants in this trial may receive, can benefit caregivers of people with cancer and diabetes. Early results suggest it boosts caregivers' confidence in managing their duties and reduces anxiety and depression in the patients they care for. The program uses tools like eco-mapping to help caregivers identify and organize their support networks. It also includes coaching to enhance problem-solving skills tailored to their needs. Overall, initial findings indicate that enCompass Humana serves as a valuable support system for caregivers, helping to reduce loneliness and improve their ability to seek support. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin E Kent, PhD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for caregivers of patients with both cancer and diabetes. It's designed to help them manage the challenges they face while providing care. Caregivers who are interested in learning new coping strategies and improving their ability to support their loved ones may benefit from participating.

Inclusion Criteria

I am at least 18 years old.

I am an unpaid caregiver for someone with stage II-IV cancer and diabetes.

I am currently undergoing cancer treatment that is not hormone therapy.

Exclusion Criteria

Caregivers unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes

Caregivers with the existence of another co-morbid disease other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol

Caregivers who participated in the intervention development phase of this intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers receive the enCompass intervention, including an 8-week coaching program and a resource booklet

8 weeks

Weekly virtual coaching sessions

Follow-up

Participants are monitored for coping self-efficacy, anxiety, and depression

6 months

Assessments at baseline, 8 weeks, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• enCompass Humana

Trial Overview The study tests 'enCompass Humana', a program offering coaching and navigation support to caregivers, aiming to improve their coping skills, reduce loneliness, and increase self-efficacy. Participants will be randomly assigned to receive this intervention or standard resources like a booklet.

How Is the Trial Designed?

Group I: caregivers Experimental Treatment 1 Intervention

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.

Group II: caregiver Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Humana Foundation

Collaborator

Trials

1

Recruited

70+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07061652

Expanding the Support of Family Caregivers of Diverse ... Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, ...

2. trialstoday.org trialstoday.org/trial/NCT07061652

Expanding the Support of Family Caregivers of Diverse ... Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input ...

3. ctv.veeva.com ctv.veeva.com/study/expanding-the-support-of-family-caregivers-of-diverse-patients-with-cancer-and-diabetes

Expanding the Support of Family Caregivers of Diverse ... This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients ...

4. app.trialscreen.org app.trialscreen.org/trials/expanding-support-family-caregivers-diverse-patients-cancer-diabetes-trial-nct07061652

Supporting Caregivers of Cancer and Diabetes Patients ... The intervention aims to improve caregiver self-efficacy, reduce anxiety and depression, and mitigate loneliness. Risks: The potential risks of ...

5. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLVspLrShR0lHycw4xMDE2MzI0N1PS0bWEARxMcz1TCxNLI3MzHUNzEwtzYzMDMNBRyksuMTCxMDUwsTRVigUA7UYU3g--

Save Selected This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12532352/

Impact of diabetes and glycemic control during cancer care ... We found that cancer patients with diabetes had survival outcomes comparable to those without diabetes, after matching for age, sex, cancer ...

7. policylab.us policylab.us/clinical-trials/l/north-carolina/condition/diabetes?page=3

North Carolina Diabetes Paid Clinical Trials & Research Studies ... This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo.