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

Multi-Year Funded Merit Award - Years 6-7: For this 2-year merit award funding, we propose to continue enrollment beyond 24-weeks and extend follow-up with participants long-term, through the patient's end of life and for 24 weeks post-patient death to test the effectiveness of Cornerstone on caregiver and patient outcomes compared to usual care. * Hypothesis Primary Aim 1: Compared to usual care, Cornerstone caregiver participants will report lower distress as measured by the Hospital Anxiety and Depression Scale in the 24 weeks prior to death. * Hypotheses Secondary Aim 1: Compared to usual care, Cornerstone participants will report better a) QOL (PROMIS Global Health 10)40,54 and b) lower burden (Montgomery-Borgatta Burden Scale)39 in the 24 weeks prior to death. * Hypotheses Aim 2: Compared to usual care, Cornerstone participants' care recipients will report a) lower distress as measured by the Hospital Anxiety and Depression Scale (HADS), b) better QOL, c) better quality of death and dying, and d) lower healthcare utilization, including EOL healthcare utilization, in the 24 weeks prior to deathAim 3: Test the long-term effects of Cornerstone on caregiver bereavement outcomes. * Hypotheses Aim 3: Compared to usual care, Cornerstone caregiver participants will report a) lower distress (HADS), b) higher QOL, c) lower burden, d) higher resilience, and e) lower grief over 24 weeks post-patient death. * Parent Study - Years 1 - 5: 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 are to assess the effectiveness of ENABLE Cornerstone over 24 weeks (Primary and Secondary Aim). The investigators will also explore implementation cost and cost effectiveness, including healthcare utilization (Aim 3) and other potential mediator/moderator effects of the intervention on coping, social support, and preparedness (Exploratory Aim). The study will recruit 206 family caregivers over the age of 21 reporting that they are the primary unpaid provider of support to a close family member or friend who has been newly-diagnosed with an advanced stage cancer within the past 60 days. Half of the participants will be randomized to ENABLE Cornerstone (n=103) which consists of 6 brief, weekly in-person/telephone sessions followed by monthly follow-up every 4 weeks as needed by participants. The other half will be assigned to a usual care condition (n=103).

Sex

All

Minimum age

21 Years

Multi-Year Funded Merit Award - Years 6-7: Because this R37 extension study proposes long-term follow-up of existing and future parent trial participants, the eligibility criteria of FCGs and patients is the same as for the parent trial as listed below.

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.

• DERIVEDOdom JN, Azuero A, Taylor RA, Young Pierce J, McGowen CL, Pisu M, Rocque G, Reed RD, Wells R, Gazaway S, Mollman S, Williams GR, Huang CS, Engler S, Bakitas MA. Palliative Care Coaching for Family Caregivers of Patients With Advanced Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2619807. doi: 10.1001/jamanetworkopen.2026.19807. PMID 42334850
• DERIVEDBechthold 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