Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 20, 2020

Keywords

ClinConnect Summary

The ENABLE Cornerstone clinical trial is studying a new approach to support family caregivers of patients with advanced cancer, especially those from underserved communities, like African-Americans and people living in rural areas of the Southern U.S. Many caregivers spend around 8 hours a day helping their loved ones but often don't receive proper training or support. This trial aims to see if a program led by trained lay navigators—who are not healthcare professionals but are trained to help—can improve the well-being of both the caregivers and the patients. The program includes short sessions on managing stress, improving caregiving skills, and making important decisions about care.

To participate in the trial, caregivers need to be unpaid family members or friends who provide regular support to a person with advanced cancer. They should either live in a rural area or be African-American and must be able to speak English. Participants will receive support through six brief sessions and ongoing follow-ups over 24 weeks. This trial is currently recruiting participants, and if successful, the program could lead to better support for caregivers and their loved ones, making it easier for them to cope during a challenging time.

Gender

ALL

Eligibility criteria

• • FAMILY CAREGIVERS
• Inclusion Criteria:
• • Self-endorsing or identified by the patient as "an unpaid spouse/partner, relative or friend who knows them well and who provides regular support due to their cancer and who does not have to live in the same dwelling"
• • Either: a) caring for a patient residing in a rural zip code (classified by the U.S. Census' Rural-Urban Commuting Area Codes (RUCAs) system as small rural, large rural, and isolated \[hereafter referred to as "rural"\]) or b) be African-American
• • Caring for a patient with advanced-stage cancer (see definition under Patient Inclusion criteria below)
• • Caregivers will NOT need to have an agreeable patient willing to participate in the study
• • English-speaking and able to complete baseline measures
• Exclusion Criteria:
• • Self-reported active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse
• • PATIENTS (data collection only)
• Inclusion Criteria:
• • Diagnosed within past 60 days of initial pre-screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, and hematologic malignancies
• • English-speaking and able to complete baseline measures
• Exclusion Criteria:
• • Receiving hospice; or
• • Medical record documentation or self-report of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.