J Nicholas Dionne-Odom1,2,3, Andres Azuero1, Richard A Taylor1, Chinara Dosse1, Avery C Bechthold1, Erin Currie1, Rhiannon D Reed4, Erin R Harrell5, Sally Engler1, Deborah B Ejem1, Nataliya V Ivankova6, Michelle Y Martin7, Gabrielle B Rocque2,3,8, Grant R Williams8, Marie A Bakitas1,2,3. 1. School of Nursing, University of Alabama at Birmingham (UAB), Birmingham, Alabama. 2. Division of Geriatrics, Gerontology, and Palliative Care, UAB Department of Medicine, Birmingham, Alabama. 3. UAB Center for Palliative and Supportive Care, Birmingham, Alabama. 4. Comprehensive Transplant Institute, UAB, Birmingham, Alabama. 5. Department of Psychology, University of Alabama, Tuscaloosa, Alabama. 6. Department of Health Services Administration, UAB, Birmingham, Alabama. 7. Department of Preventive Medicine, Center for Innovation in Health Equity Research, University of Tennessee Health Science Center, Memphis, Tennessee. 8. Division of Hematology and Oncology, Department of Medicine, UAB, Birmingham, Alabama.
Abstract
BACKGROUND: The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). METHODS: This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. RESULTS: Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. CONCLUSIONS: The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. LAY SUMMARY: To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.
BACKGROUND: The objective of this study was to assess the feasibility, acceptability, and potential efficacy of ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone-a lay navigator-led, early palliative care telehealth intervention for African American/Black and/or rural-dwelling family caregivers of individuals with advanced cancer (ClinicalTrials.gov identifier NCT03464188). METHODS: This was a pilot randomized trial (November 2019 to March 2021). Family caregivers of patients with newly diagnosed, stage III/IV, solid-tumor cancers were randomized to receive either an intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered 6 weekly, 20-minute to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, self-care, getting help, staying organized, and future planning. Feasibility was assessed according to the completion of sessions and questionnaires (predefined as a completion rate ≥80%). Acceptability was determined through intervention participants' ratings of their likelihood of recommending the intervention. Measures of caregiver distress and quality of life were collected at 8 and 24 weeks. RESULTS: Sixty-three family caregivers were randomized (usual care, n = 32; intervention, n = 31). Caregivers completed 65% of intervention sessions and 87% of questionnaires. Average ratings for recommending the program were 9.4, from 1 (not at all likely) to 10 (extremely likely). Over 24 weeks, the mean ± SE Hospital Anxiety and Depression Scale score improved by 0.30 ± 1.44 points in the intervention group and worsened by 1.99 ± 1.39 points in the usual care group (difference, -2.29; Cohen d, -0.32). The mean between-group difference scores in caregiver quality of life was -1.56 (usual care - intervention; d, -0.07). Similar outcome results were observed for patient participants. CONCLUSIONS: The authors piloted ENABLE Cornerstone, an intervention for African American and rural-dwelling advanced cancer family caregivers. The acceptability of the intervention and data collection rates were high, and the preliminary efficacy for caregiver distress was promising. LAY SUMMARY: To date, very few programs have been developed to support under-resourced cancer family caregivers. To address this need, the authors successfully pilot tested an early palliative care program, called Educate, Nurture, Advise, Before Life Ends (ENABLE) Cornerstone, for African American and rural family caregivers of individuals with advanced cancer. Cornerstone is led by specially trained lay people and involves a series of weekly phone sessions focused on coaching caregivers to manage stress and provide effective support to patients with cancer. The authors are now testing Cornerstone in a larger trial. If the program demonstrates benefit, it may yield a model of caregiver support that could be widely implemented.
Authors: Michelle Y Martin; Sara Sanders; Joan M Griffin; Robert A Oster; Christine Ritchie; Sean M Phelan; Audie A Atienza; Katherine Kahn; Michelle van Ryn Journal: Cancer Nurs Date: 2012 Jul-Aug Impact factor: 2.592
Authors: J Nicholas Dionne-Odom; Andres Azuero; Kathleen D Lyons; Jay G Hull; Tor Tosteson; Zhigang Li; Zhongze Li; Jennifer Frost; Konstantin H Dragnev; Imatullah Akyar; Mark T Hegel; Marie A Bakitas Journal: J Clin Oncol Date: 2015-03-23 Impact factor: 44.544
Authors: Liang Zeng; Gillian Bedard; David Cella; Nemica Thavarajah; Emily Chen; Liying Zhang; Margaret Bennett; Kenneth Peckham; Sandra De Costa; Jennifer L Beaumont; May Tsao; Cyril Danjoux; Elizabeth Barnes; Arjun Sahgal; Edward Chow Journal: J Palliat Med Date: 2013-04-16 Impact factor: 2.947
Authors: Tammy C Hoffmann; Paul P Glasziou; Isabelle Boutron; Ruairidh Milne; Rafael Perera; David Moher; Douglas G Altman; Virginia Barbour; Helen Macdonald; Marie Johnston; Sarah E Lamb; Mary Dixon-Woods; Peter McCulloch; Jeremy C Wyatt; An-Wen Chan; Susan Michie Journal: BMJ Date: 2014-03-07
Authors: Sandra M Eldridge; Claire L Chan; Michael J Campbell; Christine M Bond; Sally Hopewell; Lehana Thabane; Gillian A Lancaster Journal: BMJ Date: 2016-10-24
Authors: J Nicholas Dionne-Odom; Andres Azuero; Kathleen D Lyons; Jay G Hull; Anna T Prescott; Tor Tosteson; Jennifer Frost; Konstantin H Dragnev; Marie A Bakitas Journal: J Pain Symptom Manage Date: 2016-06-03 Impact factor: 3.612
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 Journal: Trials Date: 2022-06-02 Impact factor: 2.728