6-Month Cancer Family Caregiver Results from the ENABLE Cornerstone Randomized Clinical Trial

Key Message : A randomized trial of lay coach-led, telehealth intervention (ENABLE Cornerstone) for African American and/or rural-dwelling caregivers of patients with advanced cancer found no significant improvements in distress, quality of life, or burden over 24 weeks. Findings highlight the need to target interventions for caregivers experiencing elevated distress.

Abstract:

Background: 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.

Purpose: To determine the effect of a lay coach-led, early palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends [ENABLE] Cornerstone) on family caregiver outcomes over 24 weeks.

Methods: This was a 2-site, single-blind randomized clinical trial (intervention vs. usual care) (January 2020-May 2025). African American and/or rural-dwelling family caregivers were recruited from outpatient cancer clinics in two large cancer centers in the U.S. South. Intervention participants received 6 weekly coaching sessions lasting 20 to 60 minutes facilitated by a trained lay coach plus monthly follow-up. The primary outcome was distress (Hospital Anxiety and Depression scale [HADS]) over 24 weeks. Secondary outcomes were quality of life (PROMIS Global Health 10) and burden (Montgomery-Borgatta Caregiver Burden Scale).

Results: A total of 222 family caregivers were randomized, 113 to the intervention and 109 to usual care. The mean (SD) age was 55.5 (14.7) years, 169 (76.1%) were female, 114 (51.4%) were African American, and 117 (52.7%) were the patient’s spouse/partner. At week 24, no relevant between-group differences were observed between the intervention and usual care groups for the HADS anxiety (mean [SE] difference in change from baseline=0.27 [0.36]; Cohen’s d=0.06; p=.45) or HADS depression measure (mean [SE] difference in change from baseline=0.09 [0.33]; Cohen’s d=0.02; p=.81). Differences in secondary outcomes were also not significant (d range, −0.22 to 0.09).

Conclusions: This 2-site randomized trial of a telehealth intervention for African American and/or rural-dwelling caregivers of patients with advanced cancer, most of whom were not distressed at baseline, did not demonstrate clinically better distress, quality of life, or burden compared with usual care over 24 weeks. Future interventions should target distressed caregivers.

References: N/A