Palliative Care Coaching for Family Caregivers of Patients With Advanced Cancer: A Randomized Clinical Trial.

Importance: African American and rural-dwelling family caregivers of persons with newly diagnosed advanced cancer perform critical, time-intensive tasks and historically have had limited resources to support their role. Objective: To determine the effect of a lay coach-led, early palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends [ENABLE] Cornerstone) for African American and rural-dwelling family caregivers of patients with advanced cancer on caregiver and patient outcomes at 24 weeks. Design, Setting, and Participants: This single-blind randomized clinical trial was conducted from January 2020 to May 2025 at outpatient oncology clinics at 2 large cancer centers in the Southeastern US. Participants were African American and rural-dwelling family caregivers aged 21 years or older self-identifying as an unpaid close friend or family member who is involved with the day-to-day medical care of a patient with advanced cancer. Intervention: The intervention included 6 weekly, 20- to 60-minute psychosocial telephonic sessions facilitated by a trained lay coach plus monthly follow-up. Usual care consisted of mailed pamphlets outlining resources for families at each of the cancer centers. Main Outcomes and Measures: The primary outcome was caregiver distress (anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale [HADS]) at 24 weeks. Secondary outcomes were caregiver and patient quality of life (QOL; measured with the Patient-Reported Outcomes Measurement Information System Global Health Short Form), caregiver burden (Montgomery-Borgatta Caregiver Burden Scale), and patient distress (HADS). Outcomes were assessed using baseline-constrained linear mixed-effects models. Results: A total of 222 family caregivers (mean [SD] age, 55.5 [14.7] years; 169 [76.1%] female; 114 [51.4%] African American; 101 White [45.5%]; 7 other race [3.2%]) and 165 patients (mean [SD] age, 60.7 [12.2] years; 98 [59.4%] female; 79 African American [47.9%]; 84 White [50.9%]; 2 other race [1.2%]) were randomized. At week 24, no relevant between-group differences were observed in caregiver HADS anxiety (mean [SE] baseline-adjusted difference, 0.23 [0.44]; Cohen d = 0.05; 95% CI, -0.14 to 0.24; P = .60) or HADS depressive symptom scores (mean [SE] baseline-adjusted difference, 0.04 [0.41]; Cohen d = 0.01; 95% CI, -0.19 to 0.21; P = .91). For all other outcomes, 24-week differences were of small magnitude and not statistically significant. Exploratory sensitivity analyses of caregivers distressed at baseline indicated improvements in caregiver anxiety (mean [SE] baseline-adjusted difference, -1.21 [0.53]; Cohen d = -0.38; 95% CI, -0.70 to -0.05) and patient mental health QOL (mean [SE] baseline-adjusted difference, 3.00 [1.37]; Cohen d = 0.45; 95% CI, 0.04 to 0.86), but no statistically significant differences in caregiver burden (mean [SE] baseline-adjusted difference, -1.15 [0.69]; Cohen d = -0.32; 95% CI, -0.71 to 0.06) and patient depression (mean [SE] baseline-adjusted difference, -1.30 [0.71]; Cohen d = -0.37; 95% CI, -0.77 to 0.03). Conclusions: This randomized clinical trial of a telehealth intervention for African American and rural-dwelling caregivers of patients with advanced cancer found no differences in caregiver and patient outcomes at 24 weeks. However, an exploratory sensitivity analysis indicated potential improvements in caregiver anxiety and patient mental health QOL. Trial Registration: ClinicalTrials.gov Identifier: NCT04318886.