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

NCT ID: NCT06688942

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2026-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Graft-Versus-Host Disease Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Horizons Digital Health Application Group

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

Group Type EXPERIMENTAL

Horizons App Intervention

Intervention Type 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.

Interventions

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Horizons App Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Lara Traeger

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lara Traeger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20240864

Identifier Type: -

Identifier Source: org_study_id

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