Graft Vs Host DiseaseNCT06160986
Horizons Chronic Graft-Versus-Host-Disease Study
A study testing Horizons Group Intervention in people with Graft Vs Host Disease and Coping Skills, run by University of Miami at 1 site in United States.
Trial summary
This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Graft Vs Host Disease, Coping Skills, Quality of Life
- What is being tested?
- Horizons Group 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
- 27 Dec 2023to 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 participate in a group intervention in English or Spanish language
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
Official title: Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.
- Being tested
- Horizons Group Intervention
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizons Group InterventionBehavioural
The Horizons Group intervention in English or Spanish language (per participant preference) contains 8 weekly group sessions delivered via video conference by a bone marrow transplant clinician and behavioral health specialist, over approximately 8 weeks, approximately 1.5 hours per session every week. The intervention pairs state-of-the-science information about survivorship and chronic graft versus host disease with self-management strategies. Intervention sessions will be delivered via video conference (Zoom), which participants may access by computer, laptop, tablet, or smart phone. As part of the intervention, participants will have access to an intervention manual and audio-recorded relaxation exercises to support learning and skills practice.
| Study group | Role | What they receive |
|---|---|---|
| Horizons Group | Experimental | Participants will receive the Horizons Group intervention for up to 8 weeks. Receives: Behavioral: Horizons Group 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 ≥50% eligible participants enroll
Measured: Baseline (pre-intervention) to 10-week follow-up
Percentage of participant attendance
Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions
Measured: Baseline (pre-intervention) to 10-week follow-up
Percentage of participant retention
Participant retention will be demonstrated if ≥80% participants are retained in the study at week 10.
Measured: Baseline (pre-intervention) to 10-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 posted7 Dec 2023
- Study start27 Dec 2023
- Primary completion12 Dec 2024
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- 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 (estimated)
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
- NCT06160986
- Sponsor's protocol ID
- 20230656
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2023
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT06160986
- Acronym / sponsor ID
- 20230656
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Dec 2023 (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.
This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.
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 Group | Experimental | Behavioral: Horizons Group InterventionParticipants will receive the Horizons Group intervention for up to 8 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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 participate in a group intervention in English or Spanish language
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 Group InterventionThe Horizons Group intervention in English or Spanish language (per participant preference) contains 8 weekly group sessions delivered via video conference by a bone marrow transplant clinician and behavioral health specialist, over approximately 8 weeks, approximately 1.5 hours per session every week. The intervention pairs state-of-the-science information about survivorship and chronic graft versus host disease with self-management strategies. Intervention sessions will be delivered via video conference (Zoom), which participants may access by computer, laptop, tablet, or smart phone. As part of the intervention, participants will have access to an intervention manual and audio-recorded relaxation exercises to support learning and skills practice. | Behavioural | Horizons Group |
Primary outcome
Percentage of participant enrollment
Time frame: Baseline (pre-intervention) to 10-week follow-up
Participant enrollment will be demonstrated if ≥50% eligible participants enroll
Percentage of participant attendance
Time frame: Baseline (pre-intervention) to 10-week follow-up
Participant attendance will be demonstrated if ≥80% participants complete ≥4 of 8 sessions
Percentage of participant retention
Time frame: Baseline (pre-intervention) to 10-week follow-up
Participant retention will be demonstrated if ≥80% participants are retained in the study at week 10.
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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 Group Intervention in people with Graft Vs Host Disease and Coping Skills, 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 4 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 13 Apr 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: Baseline (pre-intervention) to 10-week follow-up). The study lists 3 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 13 Apr 2026.