Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

NCT05690971 | Active Not Recruiting

• 1 other identifier: 22-503
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life (QOL) longitudinal using FACT-BMT

  Up to sixteen weeks

• 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

Other Outcomes (4)

• Self-efficacy (PROMIS self-efficacy scale)

  up to sixteen weeks

• patient coping using Measure of Current Status (MOCS)

  up to sixteen weeks

• social support using Medical Outcomes Study Social Support Survey (MOS SSS)

  up to sixteen weeks

Study Arms (2)

Horizons mobile app

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

App BEHAVIORAL

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

Horizons mobile app

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Areej El-Jawahri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 23, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)