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01-12-2022 | Care | Study protocol

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

Authors: Avery C. Bechthold, Andres Azuero, Maria Pisu, Jennifer Young Pierce, Grant R. Williams, Richard A. Taylor, Rachel Wells, Kayleigh Curry, Rhiannon D. Reed, Erin R. Harrell, Shena Gazaway, Sarah Mollman, Sally Engler, Frank Puga, Marie A. Bakitas, J. Nicholas Dionne-Odom

Published in: Trials | Issue 1/2022

Abstract

Background

Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer.

Methods

This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin’s Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20–60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient’s death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient’s death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated.

Discussion

Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances.

Trial registration

ClinicalTrials.gov NCT04318886. Registered on 20 March, 2020.

Available only for authorised users

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Title: 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
Authors: Avery C. Bechthold
Andres Azuero
Maria Pisu
Jennifer Young Pierce
Grant R. Williams
Richard A. Taylor
Rachel Wells
Kayleigh Curry
Rhiannon D. Reed
Erin R. Harrell
Shena Gazaway
Sarah Mollman
Sally Engler
Frank Puga
Marie A. Bakitas
J. Nicholas Dionne-Odom
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Care
Telemedicine
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06305-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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