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

Running, not enrolling · Phase 3

Conditions studied: Cancer Metastatic, Family Members

In brief

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).

Key facts

Study ID

NCT04318886

Run by

University of Alabama at Birmingham

People needed

387

Starts

2021-01-07

Expected to finish

2027-06-30

Last updated by the study team

2026-07-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

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)
• 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 it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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