Status:
ACTIVE_NOT_RECRUITING
Lay Coach-Led Early Palliative Care for Underserved Advanced Cancer Caregivers: The Project ENABLE Cornerstone RCT
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Metastatic
Family Members
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
Many of the 2.8 million family caregivers (FCGs) of persons with advanced cancer are underserved, particularly African-Americans and rural-dwellers in the Southern U.S.. Most have poor access and awar...
Detailed Description
This hybrid type I randomized effectiveness-implementation trial is designed to answer the question "Is ENABLE Cornerstone efficacious in enhancing caregiver and patient outcomes?" The primary aims ar...
Eligibility Criteria
Inclusion
- FAMILY CAREGIVERS
- 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
- 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
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT04318886
Start Date
January 7 2021
End Date
June 30 2027
Last Update
December 17 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294