A Mobile Health Intervention in Caregivers of Patients Undergoing Hematopoietic Cell Transplantation: A Randomized Controlled Trial to Examine Health-Related Quality of Life.

Abstract

Background: Caregivers are essential in supporting cancer patients, especially those undergoing hematopoietic cell transplantation (HCT). While traditional interventions have been beneficial for improving health-related quality of life (HRQOL), they typically require significant time and staff resources. To address this, we developed the Roadmap mHealth app, which incorporates resilience-building features based on positive psychology. The app integrates Fitbit^® devices to monitor and visualize steps, sleep, and self-reported mood in the Roadmap app. A two-arm randomized controlled trial (RCT) was conducted to evaluate the impact of Roadmap's positive activities on caregiver HRQOL, measured by PROMIS^® Global Health (physical and mental components), at day-120 post-transplant compared to assessment-only controls.

Results: From September 08, 2020 to July 31, 2023, 168 dyads enrolled in the Roadmap study (82 intervention, 87 control). At day-120 post-HCT, there were no significant differences in PROMIS^® Global Mental Health (48.18 vs. 48.16) or Global Physical Health (50.19 vs. 49.52) T-scores between the intervention and control arms. However, among caregivers who used positive activities and chat forum features in the intervention arm, daily mood significantly improved over time (β=0.0082, P<0.001, 95% CI= [0.0060, 0.0010]). Improved daily mood scores were positively associated with better PROMIS^® Global Mental Health at days 30 and 120 post-HCT (β=0.6076, P=0.03, 95% CI=[0.0494, 1.166]). The Fitbit^® device and Roadmap app also received net favorable ratings in feasibility and acceptability, indicating that they were generally easy-to-understand, set up, and use, and superior Mobile App Rating Scale (MARS) scores compared to published mental health apps, with no significant differences between study arms. Compliance with the intervention or control app declined over time.

Conclusions: While the primary outcome, PROMIS^® Global Health, did not differ between arms, caregivers who engaged in positive activities and chat forum through the app experienced a significant improvement in mood compared to those who did not. Additionally, caregivers reported the study as feasible and acceptable over the 120-day study period. Future directions for the Roadmap app are discussed based on these findings.

Trial registration: ClinicalTrials.gov: NCT04094844, Registered 09-16-2019.