Psychosocial digital application for caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT): A randomized controlled trial.

11000 Background: Caregivers (i.e., relatives and friends) of patients undergoing HSCT struggle with considerable quality of life (QOL) impairments and psychological strain before, during, and after HSCT. However, few interventions address the supportive care needs of these caregivers while prioritizing accessibility and scalability. We assessed the efficacy of a self-guided digital application, called BMT-CARE App, for improving HSCT caregivers' QOL, burden, mood symptoms, coping skills, and self-efficacy. Methods: We conducted a single-center randomized trial of the BMT-CARE App for HSCT caregivers, compared with usual care (UC). Eligible individuals were adults caring for patients with hematologic malignancies undergoing autologous or allogeneic HSCT at a tertiary care center and were randomly assigned 1:1 to the BMT-CARE App or UC, stratified by transplant type. Intervention participants engaged with the app before transplant and up to 60 days post-HSCT. The app comprises five modules integrating psychoeducation, evidence-based behavior change, and stress management, delivered through interactive features, educational games, and videos. Participants completed self-report measures at baseline and day 60 post-HSCT. The primary endpoint was QOL at day 60 post-HSCT assessed by the CareGiver Oncology QOL (CarGOQOL) questionnaire. We also assessed caregiving burden (Caregiver Reaction Assessment [CRA]), anxiety and depression symptoms (Hospital Anxiety and Depression Scale [HADS]), posttraumatic stress disorder (PTSD) symptoms (PTSD Checklist [PCL-5]), coping skills (Measure of Current Status-A [MOCS-A]), and self-efficacy (Cancer Self-Efficacy Scale-transplant [CASE-t]). We used analysis of covariance controlling for baseline criterion values to assess the effect of the intervention on study outcomes. Results: From 2/2023 - 7/2024, we enrolled 125 of 174 approached (71.8%) caregivers (BMT-CARE App n = 62, UC n = 63; median age = 58.7 years [range, 27.8-78.6]). Most participants were spouses (71.2% [89/125]). Participants assigned to BMT-CARE App used the app for a mean of 133.2 minutes (SD = 101.9). At 60 days post-HSCT, intervention participants reported better QOL compared to those assigned to UC (76.2 vs 69.9, p = 0.006]), exceeding the 5-point clinically meaningful difference on the CarGOQOL. BMT-CARE App participants also reported lower caregiving burden (11.2 vs 12.3, p = 0.024), depression (3.8 vs 5.6, p = 0.002), and PTSD symptoms (26.0 vs 31.3, p = 0.011), and better coping skills (33.9 vs 28.2, p = 0.003). The two groups did not differ significantly in anxiety symptoms or self-efficacy at day 60 post-HSCT. Conclusions: The BMT-CARE App, a psychosocial digital health intervention, led to substantial improvements in QOL, caregiving burden, depression and PTSD symptoms, and coping skills in caregivers of HSCT recipients. Clinical trial information: NCT05709912 .