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

NCT04318886 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: IRB-300005045R37CA252868
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

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 awareness of community-based palliative care services and have received no formal support or training despite providing assistance to their relatives an average of 8 hrs/day. Providing intense care and witnessing a close friend or family member struggle with advanced cancer can result in FCGs experiencing marked distress, particularly as their care recipients near end of life (EOL). Reports from NCI and NINR caregiving summits, systematic reviews, and the National Academy of Medicine have highlighted major limitations of cancer caregiver interventions, including a lack of attention to underserved populations and cost, poor scalability, over reliance on highly-trained professionals (e.g., nurses, psychologists, behavioral therapists), lengthy sessions over a short duration, and a lack of demonstrated impact on patient outcomes and healthcare utilization. To address this gap, the investigators have developed and tested feasibility and acceptability of a lay navigator-led early palliative care intervention called ENABLE Cornerstone for rural and minority family caregivers of persons with advanced cancer in the Southern U.S.. Evolving out of the team's prior trials and community stakeholder formative evaluation work, this multicomponent intervention is based on Pearlin's Stress-Health Process Model where lay navigators, overseen by an interdisciplinary outpatient palliative care team, employ health coaching techniques and caregiver distress screening to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement. This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve family caregiver (Aim 1) and patient outcomes (Aim 2) and will evaluate implementation costs, cost effectiveness and healthcare utilization (Aim 3), over 24 weeks with 206 family caregivers and their patients with newly-diagnosed advanced cancer. To maximize recruitment, the investigators will recruit from two community cancer centers in Birmingham, AL and Mobile, AL. Our theory-driven, standardized approach is innovative because it uses lay navigators in collaboration with a palliative care interdisciplinary team to promote caregiver activation, skills and knowledge enhancement, as opposed to other difficult-to-implement intervention models that rely mostly on delivery of services by advanced practice professionals providing lengthy sessions over a short duration. If effectiveness is established, the ENABLE Cornerstone intervention offers a highly scalable and reproducible model of formal caregiver support that would be primed for dissemination and implementation.

Conditions

Cancer Metastatic; Family Members

Keywords

palliative care; supportive care; family caregiver; rural; African American; telehealth

Outcome Measures

Primary Outcomes (1)

• Distress (Family Caregiver)

  Hospital Anxiety and Depression Scale - 14 items total (α=.92), 7 items measure anxiety (e.g., feeling tense, restless, worry), 7 items measure depressive symptoms (e.g., cheerfulness, feeling slowed down). Higher scores=worse anxiety/depression.

  Baseline to 24 weeks

Secondary Outcomes (5)

• Quality of Life (Family Caregiver)

  Baseline to 24 weeks

• Burden (Family Caregiver)

  Baseline to 24 weeks

• Distress (Patient)

  Baseline to 24 weeks

• Quality of Life (Patient)

  Baseline to 24 weeks

• Healthcare Utilization (Patient)

  Baseline to 24 weeks

Other Outcomes (1)

• Implementation costs and cost effectiveness

  Baseline to 24 weeks

Study Arms (2)

Usual Care

NO INTERVENTION

Project ENABLE Cornerstone

EXPERIMENTAL

Behavioral: ENABLE Cornerstone

Interventions

ENABLE Cornerstone BEHAVIORAL

The ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone intervention is led by a specially-trained lay coach who is overseen by an interdisciplinary outpatient palliative care team, who employs health coaching techniques and caregiver distress assessment to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement.

Project ENABLE Cornerstone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Caregivers will NOT need to have an agreeable patient willing to participate in the study
• English-speaking and able to complete baseline measures

You may not qualify if:

• 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)
• 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
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Bechthold AC, Azuero A, Pisu M, Pierce JY, Williams GR, Taylor RA, Wells R, Curry K, Reed RD, Harrell ER, Gazaway S, Mollman S, Engler S, Puga F, Bakitas MA, Dionne-Odom JN. The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers. Trials. 2022 Jun 2;23(1):452. doi: 10.1186/s13063-022-06305-w.

  PMID: 35655285 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: January 7, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)