Randomized controlled trial of a psychosocial digital application (THRIVE-MM) for patients living with multiple myeloma.

Abstract

1513 Background: Patients living with multiple myeloma (MM) struggle with considerable quality of life (QOL) impairments, fatigue, and psychological distress throughout their illness course. However, few accessible and scalable interventions address the supportive care needs of these patients. We assessed the efficacy of a self-guided psychosocial digital application, THRIVE-MM, for improving QOL, fatigue, and psychological distress in patients living with MM. Methods: We conducted a single-center randomized controlled trial of THRIVE-MM vs. usual care for adults living with MM. Eligibility criteria included patients newly diagnosed with MM receiving first line therapy, those with relapsed MM receiving second- or third-line therapy, or those with MM on maintenance therapy. Participants were randomly assigned 1:1 to THRIVE-MM or usual care, stratified by line of therapy (first line vs. second/third line vs. maintenance) and were given access to the THRIVE-MM digital app up to 8 weeks after enrollment. THRIVE-MM comprises five modules designed to improve patients’ physical and psychological symptoms via psychoeducation and evidenced-based self-management skills training for behavioral change and coping, delivered through interactive activities, educational games, and videos. Participants completed self-report measures at baseline and at week-8 after enrollment. The primary endpoint was QOL at week-8 assessed by the Functional Assessment of Cancer Therapy (FACT)-MM. Secondary outcomes were fatigue (FACT-Fatigue), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), and symptoms of posttraumatic stress disorder (PTSD Checklist). We used analysis of covariance controlling for baseline criterion value to assess the effect of THRIVE-MM on outcomes. Results: From 12/2023-6/2025, we enrolled 59.1% (120/203) of eligible patients (mean (SD) age = 68.2 (10.0) years; 49.2% women). Mean (SD) use time for THRIVE-MM in the intervention group was 221.9 (197.1) minutes. At week-8, QOL did not differ significantly between the two groups (THRIVE-MM; 125.2 vs. usual care; 125.1, p = 0.977]). THRIVE-MM participants reported lower fatigue (40.6 v. 37.6, p = 0.012) and lower depression symptoms (2.5 vs. 3.4, p = 0.044) at week-8. Anxiety or PTSD symptoms did not differ significantly between the two groups at week-8. Conclusions: THRIVE-MM, a psychosocial digital health intervention, decreased fatigue and depression symptoms but not QOL among patients living with MM. Clinical trial information: NCT06073353 .