A Lay Navigator-Led Early Palliative Care Intervention for African American and Rural Family Caregivers of Individuals with Advanced Cancer (Project Cornerstone): A Pilot Randomized Trial

• Published in: Journal of pain and symptom management 2022-05, Vol.63 (5), p.859-860
• Main Authors: Dionne-Odom, James, Azuero, Andres, Dosse, Chinara, Bechthold, Avery, Currie, Erin, Reed, Rhiannon, Harrell, Erin, Engler, Sally, Ejem, Deborah, Ivankova, Nataliya, Rocque, Gabrielle, Williams, Grant, Bakitas, Marie
• Format: Article
• Language: English
• Subjects: African Americans; Cancer; Caregivers; Clinical trials; Coaching; Coping; Difference scores; Early intervention; Efficacy; Feasibility; Newly diagnosed; Palliative care; Psychological distress; Quality of life; Questionnaires; Rural communities; Self care; Stress management; Telemedicine; Tumors
• ISSN: 0885-3924; 1873-6513
• DOI: 10.1016/j.jpainsymman.2022.02.043

1. Verbalize understanding of the role families play in supporting patients with advanced cancer 2. State outcomes of a pilot randomized trial of a lay navigator-led intervention to mitigate caregiver distress Patients with advanced cancer often depend on receiving complex care and daily support from family caregivers, a role that can be particularly burdensome for underserved groups, including African American and rural-dwelling people. Assess the feasibility, acceptability, and potential efficacy of Project ENABLE Cornerstone, a lay navigator–led, early palliative telehealth intervention for African American or rural-dwelling caregivers of people with advanced cancer. Pilot randomized controlled trial (November 2019-March 2021). Family caregivers of patients with newly diagnosed Stage III/IV solid tumor cancers were randomly assigned to intervention or usual care. Intervention caregivers were paired with a specially trained lay navigator who delivered a series of 6 weekly 20- to 60-minute telehealth coaching sessions plus monthly follow-up for 24 weeks, reviewing skills in stress management, coping, self-care, getting help, staying organized, and planning for the future. Feasibility was assessed by completion of sessions and questionnaires. Acceptability was determined through intervention participants’ ratings of their likelihood to recommend. Measures of caregiver distress and quality of life were collected at 12 and 24 weeks. Sixty-three family caregivers were randomly assigned to usual care (32) or to the intervention (31). Caregivers completed 61% of intervention sessions and 85% of questionnaires. The average intervention group caregiver rating for recommending the program to others was 9.4 (scale: 1, not at all likely; 10, extremely likely). Over 24 weeks, the mean (SE) Hospital Anxiety and Depression score improved by 0.3 (1.44) points in the intervention group and worsened by 1.99 (1.39) in the usual care group (difference, –2.29, d = –0.32). The mean between-group difference scores in Caregiver Quality of Life was –1.56 (usual care minus intervention, d = –0.07). We successfully piloted ENABLE Cornerstone, an intervention for underserved 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. Results have informed a larger trial, which is now under way.