Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Patients With Chronic Graft-Versus-Host Disease (GVHD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Graft-Versus-Host Disease
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
- Status
- Active, Not Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Investigators
El-Jawahri, Areej,M.D.
Principal Investigator
Massachusetts General Hospital
Eligibility 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.
Outcomes
Primary Outcomes
Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
Time Frame: 8 Weeks
Compare patient QOL (FACT-BMT) between usual care and Horizon at 8 weeks using ANCOVA. FACT-BMT score range 0-164, with higher scores indicating better quality of life.
Secondary Outcomes
- Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)(up to sixteen weeks)
- Depression symptoms using HADS-Depression(up to sixteen weeks)
- Chronic GVHD symptom burden (Lee Scale)(up to sixteen weeks)
- Quality of life (QOL) longitudinal using FACT-BMT(Up to sixteen weeks)