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 sta...
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2025-07-01
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| Online Access: | https://doi.org/10.1186/s44247-025-00165-5 |
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| author | Xiao Cao Michelle Rozwadowski Thomas M. Braun Noelle E. Carlozzi Afton L. Hassett Amanda K. Johnson Evan Shereck David A. Hanauer Sung Won Choi |
| author_facet | Xiao Cao Michelle Rozwadowski Thomas M. Braun Noelle E. Carlozzi Afton L. Hassett Amanda K. Johnson Evan Shereck David A. Hanauer Sung Won Choi |
| author_sort | Xiao Cao |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9aa3cb6f0bb2490d8f765eacf0eafd2a |
| institution | Kabale University |
| issn | 2731-684X |
| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-9aa3cb6f0bb2490d8f765eacf0eafd2a2025-08-20T03:46:16ZengBMCBMC Digital Health2731-684X2025-07-013111510.1186/s44247-025-00165-5A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of lifeXiao Cao0Michelle Rozwadowski1Thomas M. Braun2Noelle E. Carlozzi3Afton L. Hassett4Amanda K. Johnson5Evan Shereck6David A. Hanauer7Sung Won Choi8Department of Pediatrics, University of MichiganDepartment of Pediatrics, University of MichiganDepartment of Biostatistics, School of Public Health, University of MichiganDepartment of Physical Medicine and Rehabilitation, University of MichiganDepartment of Anesthesiology, University of MichiganDepartment of Pediatrics, University of UtahDepartment of Pediatrics, Oregon Health & Science UniversityDepartment of Learning Health Sciences, University of MichiganDepartment of Pediatrics, University of MichiganAbstract 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.https://doi.org/10.1186/s44247-025-00165-5Family caregiversHematopoietic cell transplantation (HCT)Health-related quality of life (HRQOL)Digital technologiesMobile health (mHealth)Positive psychology |
| spellingShingle | Xiao Cao Michelle Rozwadowski Thomas M. Braun Noelle E. Carlozzi Afton L. Hassett Amanda K. Johnson Evan Shereck David A. Hanauer Sung Won Choi A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life BMC Digital Health Family caregivers Hematopoietic cell transplantation (HCT) Health-related quality of life (HRQOL) Digital technologies Mobile health (mHealth) Positive psychology |
| title | A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life |
| title_full | A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life |
| title_fullStr | A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life |
| title_full_unstemmed | A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life |
| title_short | A mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation: a randomized controlled trial to examine health-related quality of life |
| title_sort | mobile health intervention in caregivers of patients undergoing hematopoietic cell transplantation a randomized controlled trial to examine health related quality of life |
| topic | Family caregivers Hematopoietic cell transplantation (HCT) Health-related quality of life (HRQOL) Digital technologies Mobile health (mHealth) Positive psychology |
| url | https://doi.org/10.1186/s44247-025-00165-5 |
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