Mobile app to help patients with 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)
This study is testing a mobile app called Horizons to see if it can help improve the quality of life and reduce symptoms for adults with chronic graft-versus-host disease after a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05690971 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of a psychosocial mobile app called Horizons in improving the quality of life, symptom burden, and psychological distress for patients suffering from chronic graft-versus-host disease (GVHD). Participants will be randomly assigned to receive either the Horizons app along with usual care or usual care alone. The study aims to enroll approximately 120 adult patients who have undergone allogeneic stem cell transplant and are experiencing moderate to severe chronic GVHD. The study duration for each participant is expected to be up to sixteen weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone allogeneic hematopoietic stem cell transplant and are experiencing moderate to severe chronic GVHD.
Not a fit: Patients with acute or unstable psychiatric or cognitive conditions that hinder informed consent or compliance with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could significantly enhance the quality of life and coping mechanisms for patients living with chronic GVHD.
How similar studies have performed: While the use of mobile apps for chronic disease management is gaining traction, this specific approach for chronic GVHD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplant (HCT). * Have moderate to severe chronic GVHD based on their oncology clinician assessment as documented in the Electronic Health Record. * Ability to comprehend and speak English as the HORIZONs app is only available in English. Exclusion Criteria: -Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Areej El-Jawahri, MD — Massachusetts General Hospital
- Study coordinator: Areej El-Jawahri, MD
- Email: AEL-JAWAHRI@PARTNERS.ORG
- Phone: 617-643-4003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.