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 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.

A Rapid Review of Uses and Outcomes of Telehealth Care in Rural and Remote Regions in the United States

“…In addition, the caregivers experienced reduced anxiety and depression with improvements in quality of life. These findings support ongoing evidence of the value of telehealth, including telephone delivery, for rural and remote patients and caregivers 24,25,30 …”

“…The use of telehealth for palliative care and hospice services was frequently grouped by disease, such as advanced cancer, 25 heart failure, 13 head and neck cancer, 21 and end-stage renal failure 14 . These services included direct communication between the provider and the patient/caregiver, medication management, serving as peer-to-peer consultant role for rural palliative care and hospice teams, and providing education for these rural teams needing skills to care for unique populations, such as children.…”

“…16,21,30 Pediatric palliative care and hospice programs experience insufficient policy initiatives, lack of trained providers, missing pediatric advance directives, and issues with cultural/social beliefs regarding pediatric death and dying. 17,18,28,29 Uses of Telehealth The use of telehealth for palliative care and hospice services was frequently grouped by disease, such as advanced cancer, 25 heart failure, 13 head and neck cancer, 21 and end-stage renal failure. 14 These services included direct communication between the provider and the patient/caregiver, medication management, serving as peer-to-peer consultant role for rural palliative care and hospice teams, and providing education for these rural teams needing skills to care for unique populations, such as children.…”

“…These findings support ongoing evidence of the value of telehealth, including telephone delivery, for rural and remote patients and caregivers. 24,25,30 Weaver et al 17 coupled pediatric palliative care with adult-trained rural hospice teams to support children with cancer and their family caregivers. Although the average time of enrollment in hospice was only 21.6 days, symptom management, support, and care coordination were identified as valuable aspects of this coupled model of care.…”

Inequities Among Cancer Caregivers with Diverse Identities: A Review of the Literature and Future Directions

“…One promising intervention undergoing testing, Project ENABLE Cornerstone is an early palliative care coaching intervention for Black caregivers of patients with advanced cancer that aims to improve caregivers' skills in coping, decision-making, and communicating needs. [33].…”