Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

NCT ID: NCT05690971

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2026-06-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

App

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leukemia and Lymphoma Society

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawahri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

22-503

Identifier Type: -

Identifier Source: org_study_id