NCT06073353

Psychosocial Mobile Application (THRIVE-M) for Patients With Multiple Myeloma

Randomized Controlled Trial of a Psychosocial Mobile Application (THRIVE-M) for Patients Living With Multiple Myeloma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to evaluate whether a psychosocial mobile application (THRIVE-M), is efficacious for improving quality of life, psychological distress, and fatigue in patients living with multiple myeloma compared to usual care.

Detailed description

Multiple myeloma, the second most common hematologic malignancy, can be associated with severe end-organ destruction and life-threatening complications (e.g., kidney failure, infection, anemia) resulting in significant morbidity (e.g., pain syndromes, fatigue). The protracted course and treatment of multiple myeloma is also characterized by physical symptoms that can undermine psychological well-being, functioning, and quality of life across the illness trajectory and care continuum. Despite the high psychological burden that may accompany life with multiple myeloma, the special mental health workforce needed to adequately address their psychological needs is limited. Hence, mobile application-delivered psychosocial interventions offer an innovative approach to overcome the shortage of psychosocial services to support the unique needs of patients living with multiple myeloma. With no psychosocial mobile application interventions for patients living with multiple myeloma, we developed a patient-centered, population-specific, mobile-application psychosocial intervention, THRIVE-M, tailored to the unique needs of patients living with multiple myeloma. With this study, we will establish the impact of THRIVE-M on patient-reported outcomes compared to usual care. The study will use validated questionnaires to measure patients' quality of life, psychological distress symptoms, fatigue, and self-management targets like coping, spiritual well-being, and self-efficacy. Study questionnaires will be completed in the hospital or clinic, with an option to also complete them remotely via a secure web link or a mailed paper copy. Divine Mercy University is funding this research study.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BEHAVIORAL	THRIVE-M	THRIVE-M is a self-administered psychosocial mobile application for patients living with multiple myeloma that includes the following five modules: 1. Health module - teaching patients about physical symptoms and strategies to cope with physical symptoms 2. Relationships module - helping patients articulate different support needs and communication styles in navigating relationships 3. emotions module - helping patients identify connections between thoughts, feelings, and behaviors, as well as helpful states of mind and gratitude 4. Lifestyle module - helping patients practice skills for saving up energy and using self-care strategies 5. Reflection module - teaching patients to reflect on their lives, meaningful relationships, and sense of purpose. Each module takes about 15-20 minutes to complete and participants will be instructed to complete all modules within an eight-week period.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-04-01
• Completion: 2026-03-31
• First posted: 2023-10-10
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States