Chronic Graft-Versus-Host DiseaseNCT06688942
Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease
A study testing Horizons App Intervention in people with Chronic Graft-Versus-Host Disease and Quality of Life, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Graft-Versus-Host Disease, Quality of Life
- What is being tested?
- Horizons App Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Horizons App Intervention
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizons App InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Horizons Digital Health Application Group | Experimental | Participants will receive the Horizons mobile application for up to 6 weeks. Receives: Behavioral: Horizons App Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participant enrollment
Participant enrollment will be demonstrated if ≥60% eligible participants enroll.
Measured: Up to 8-week follow-up
Percentage of participant retention
Participant retention will be demonstrated if ≥80% participants are retained in the study.
Measured: Up to 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start4 Dec 2024
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Traeger, University of Miami
- Investigators
- Lara Traeger, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688942
- Sponsor's protocol ID
- 20240864
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT06688942
- Acronym / sponsor ID
- 20240864
- Conditions
- Chronic Graft-Versus-Host Disease, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Horizons Digital Health Application Group | Experimental | Behavioral: Horizons App InterventionParticipants will receive the Horizons mobile application for up to 6 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horizons App InterventionParticipants 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. | Behavioural | Horizons Digital Health Application Group |
Primary outcome
Percentage of participant enrollment
Time frame: Up to 8-week follow-up
Participant enrollment will be demonstrated if ≥60% eligible participants enroll.
Percentage of participant retention
Time frame: Up to 8-week follow-up
Participant retention will be demonstrated if ≥80% participants are retained in the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Graft-Versus-Host Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Traeger, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizons App Intervention in people with Chronic Graft-Versus-Host Disease and Quality of Life, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participant enrollment (time frame: Up to 8-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.