NCT05690971

Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Patients With Chronic Graft-Versus-Host Disease (GVHD)

• 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

The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)

Detailed description

Frequently patients living with chronic GVHD experience physical and emotional symptoms during the course of illness that impacts their quality of life. Patients also often report difficulty managing many of the tasks they need to do to manage their chronic GVHD. They also frequently have a lot of questions about chronic GVHD and the expected trajectory of this illness. The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, and psychological distress in patients with chronic GVHD * This study will randomly assign participants to either receiving Horizons plus usual care or usual care alone. * Enrolled participants will be on the research study for up to sixteen weeks and it is expected that about 120 people will take part in this research study. The Leukemia and Lymphoma Society is supporting this research by providing funding.

Conditions

• Chronic Graft-Versus-Host Disease
• Allogeneic Stem Cell Transplant

Interventions

Type	Name	Description
BEHAVIORAL	App	HORIZONS is self-administered with several features to promote engagement and health behavior change including gamification strategies, videos of chronic GVHD survivors, and optional content. HORIZONS includes five interactive modules to be completed during an eight week period. HORIZONS also includes a sixth optional helpful resources section with a review of the domains and skills covered in the first five modules
BEHAVIORAL	Usual Care	Patients in the usual care group will receive usual care from the transplant oncology team including all the supportive care measures implemented by the transplant oncology team.

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2023-01-19
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States