Support for family caregivers of advanced cancer patients in underserved areas
Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: the Project ENABLE Cornerstone RCT
This study tests if a support program for family caregivers of advanced cancer patients can help them feel better and improve care for their loved ones compared to usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 412 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT04318886 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the ENABLE Cornerstone program, which provides support to family caregivers of patients with advanced cancer. The study involves 206 family caregivers who will be randomly assigned to either the ENABLE Cornerstone intervention or usual care. The intervention consists of six brief weekly sessions followed by monthly follow-ups, focusing on enhancing caregiver and patient outcomes over a 24-week period. The trial also aims to assess implementation costs and healthcare utilization related to the intervention.
Who should consider this trial
Good fit: Ideal candidates are family caregivers over 21 years old, providing unpaid support to a relative or friend with newly diagnosed advanced cancer, particularly those from rural areas or identifying as African-American.
Not a fit: Patients who do not have a family caregiver or those with severe mental health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the well-being and coping mechanisms of family caregivers in underserved populations.
How similar studies have performed: Previous studies have indicated that caregiver interventions can be effective, but this specific approach targeting underserved populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Sally Engler, MPH
- Email: sengler@uab.edu
- Phone: (205) 996-7564
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.