Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease

NCT06688942 | Active Not Recruiting

• 1 other identifier: 20240864
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to learn if the Horizons mobile application is feasible for survivors of allogeneic hematopoietic stem cell transplant who have chronic graft-versus-host disease. Participants will be asked to complete surveys and use the Horizons mobile application.

Conditions

Chronic Graft-Versus-Host Disease; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Percentage of participant enrollment

  Participant enrollment will be demonstrated if ≥60% eligible participants enroll.

  Up to 8-week follow-up

• Percentage of participant retention

  Participant retention will be demonstrated if ≥80% participants are retained in the study.

  Up to 8-week follow-up

Study Arms (1)

Horizons Digital Health Application Group

EXPERIMENTAL

Participants will receive the Horizons mobile application for up to 6 weeks.

Behavioral: Horizons App Intervention

Interventions

Horizons App Intervention BEHAVIORAL

Participants will receive access to the Horizons app intervention. The intervention pairs patient-centered information about chronic graft-versus-host disease with self-management strategies. Within each module, patients will engage in didactics and exercises that are relevant to the participant's chronic graft-versus-host disease concerns. The app contains 6 digital modules delivered via tablet over approximately 6 weeks. Each module should take up to approximately 20 minutes and are self-guided.

Horizons Digital Health Application Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent allogeneic hematopoietic stem cell transplant
• Have moderate to severe chronic graft-versus-host disease
• Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
• Able to use an Ipad to participate in the Horizons app intervention
• Able to participate in study procedures in English

You may not qualify if:

• comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
• Vulnerable patients, defined here as prisoners and pregnant women

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

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

Study Officials

• Lara Traeger, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)