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)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Allogeneic Stem Cell Transplant; Chronic Graft-Versus-Host Disease
• Intervention / Treatment: Behavioral: App; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Horizons mobile app; Participants randomly assigned to the Horizons group, will use the Horizons app over an eight-week period in addition to receiving usual care from transplant team. Participants will complete study questionnaires at the time of enrollment (baseline) and at eight and sixteen weeks after enrollment	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
Active Comparator: Usual Care; Participant 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. Participants will complete study questionnaires at the time of enrollment (baseline) nad at eight and sixteen weeks after enrollment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL): Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	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.	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL) longitudinal using FACT-BMT	Compare patient QOL (FACT-BMT) longitudinally between Horizons and usual care group using mixed linear effect models. FACT-BMT score range 0-164, with higher scores indicating better quality of life.	Up to sixteen weeks
Anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS-Anxiety)	Compare anxiety symptoms (HADS-Anxiety) between study groups. The HADS anxiety subscale range from 0-21 with higher scores indicating worse anxiety symptoms	up to sixteen weeks
Depression symptoms using HADS-Depression	Compare depression symptoms (HADS-depression) between study groups. The HADS depression subscale range from 0-21 with higher scores indicating worse depression symptoms	up to sixteen weeks
Chronic GVHD symptom burden (Lee Scale)	compare chronic GVHD symptom burden (Lee Scale) between the study groups. The Lee Scale ranges from 0-100 with higher scores indicating worse symptom burden	up to sixteen weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy (PROMIS self-efficacy scale)	Compare self-efficacy (PROMIS-self-efficacy scale) between the study groups. The PROMIS self-efficacy for managing symptoms scale ranges from 0-100 with higher scores indicating better self-efficacy	up to sixteen weeks
patient coping using Measure of Current Status (MOCS)	Comparing coping (MOCS) between study groups (MOCS score range 0-52, with higher scores indicating greater coping skill).	up to sixteen weeks
social support using Medical Outcomes Study Social Support Survey (MOS SSS)	Compare patient social support (MOS SSS) between study groups. MOS SSS score range 0-100, with higher scores indicating greater support.	up to sixteen weeks
Usability of the Horizons app using the system usability scale	We will use the system usability scale at 8 weeks post-intervention (for those randomized to Horizons) to assess the usability of HORIZONS. the system usability scale score range from 0-100 with higher scores indicating better usability	eight weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: The Leukemia and Lymphoma Society
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Allogeneic Stem Cell Transplant; Chronic Graft-Versus-Host Disease
• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Amino Acids, Peptides, and Proteins; Proteins; Macromolecular Substances; Multiprotein Complexes; Amyloid
• Other Study ID Numbers: 22-503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No