A lay navigator‐led, early palliative care intervention for African American and rural family caregivers of individuals with advanced cancer (Project Cornerstone): Results of a pilot randomized trial
Open accessAbstract
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.
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The study protocol has been previously published and is available on ClinicalTrials.gov.
“The study protocol has been previously published12 and is available on ClinicalTrials.gov.”
From Palliative Care Coaching for Family Caregivers of Patients With Advanced Cancer (2026) · cites this paper as [12]
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- Authors
- Dionne‐Odom, J. N., Azuero, A., Taylor, R. A., Dosse, C., Bechthold, A. C., Currie, E., Reed, R. D., Harrell, E. R., Engler, S., Ejem, D. B., Ivankova, N. V., Martin, M. Y., Rocque, G. B., Williams, G. R., & Bakitas, M. A.
- Affiliations
- School of Nursing University of Alabama at Birmingham (UAB) Birmingham Alabama
- University of Alabama at Birmingham (US)
- University of Alabama (US)
- University of Tennessee Health Science Center (US)
- ORCID
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2021-12-07
- Volume
- 128
- Issue
- 6
- Pages
- 1321-1330
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- PMC
- PMC8882155
- OpenAlex
- W4200528096
- Cited by
- 67
- References
- 34
- Citations by year
- 2026: 15 · 2025: 14 · 2024: 20 · 2023: 14 · 2022: 4
- FWCI
- 8.23
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Cancer (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Nursing Research (R00NR015903)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
- Health Sciences › Health Professions › Pharmacy › Nursing care and research
- Keywords
- family caregivers, advanced cancer, early palliative care, telehealth coaching, African American caregivers, rural caregivers, caregiver distress, caregiver quality of life, feasibility and acceptability, stress management, self-care, future planning, patient-reported outcomes, patient-reported quality of life
- MeSH terms
- Black or African American, Humans, Neoplasms, Palliative Care, Pilot Projects, Quality of Life, Caregivers
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