Bone Marrow Transplant ComplicationsHORIZONSNCT06910969
Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease
A study testing HORIZONS Intervention in people with Bone Marrow Transplant Complications and Graft-versus-Host Disease, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Transplant Complications, Graft-versus-Host Disease
- What is being tested?
- HORIZONS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2025to 1 Feb 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years) who have undergone allogeneic HCT
- Have moderate to severe cGVHD based on patient-report
- Have ability to participate in English or Spanish language group telehealth intervention.
Who cannot join
- Patients with mild cGVHD based on their self-report.
- Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
- Patients with active relapsed disease requiring therapy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Areej El-Jawahri, 617-724-4000, ael-jawahri@mgb.org
Areej El-Jawahri, MD
- Recruiting
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Lara Traeger, PhD, 305-243-5302, ltraeger@miami.edu
Lara Traeger, PhD
About this study
Official title: Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
Read the detailed description
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease.
Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care.
Participation in this study is expected to last up to 18 weeks after enrollment.
The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.
- Being tested
- HORIZONS Intervention, Minimally enhanced usual care
- Keywords
- neoplasms, hematologic diseases, neoplasms by site, hematologic neoplasms, graft-versus-host disease
- Medical subject headings
- Graft vs Host Disease, Neoplasms, Hematologic Diseases, Neoplasms by Site, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HORIZONS InterventionBehavioural
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Minimally enhanced usual careBehavioural
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
| Study group | Role | What they receive |
|---|---|---|
| HORIZONS intervention | Experimental | Participants randomized to HORIZONS plus usual care will complete the following:
* Questionnaires at baseline, and weeks 10 and 18
* Receive the HORIZONS intervention from enrollment and for up to 8 weeks. HORIZONS is an 8-session multidisciplinary, patient-centered intervention that combines medical and psychosocial expertise to enhance self-management and quality of life.
* Receive usual care as determined by their local clinicians Receives: Behavioral: HORIZONS Intervention |
| Minimally enhanced usual care | Active comparator | Participants randomized to usual care will complete the following
* Questionnaires at baseline, and weeks 10 and 18 after enrollment
* Receive a standardized booklet containing evidence-based information on chronic GVHD management and HCT survivorship recommendations as well as receive care as determined by their local oncologists Receives: Behavioral: Minimally enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
Measured: At 10 weeks post-enrollment
Secondary outcomes (3)
Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms
Measured: At 10 weeks post enrollment
Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Anxiety)
Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms.
Measured: At 10 weeks post enrollment
Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale
Compare chronic graft versus host disease symptoms as measured by the Lee Symptom Scale. The Lee Symptom Scale ranges from 0 -100 with higher scores indicating worse symptomatology
Measured: At 10 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start13 Aug 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami Sylvester Comprehensive Cancer Center
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910969
- Sponsor's protocol ID
- 24-651
- Acronym
- HORIZONS
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Areej El-Jawahri (ael-jawahri@mgb.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT06910969
- Acronym / sponsor ID
- HORIZONS / 24-651
- Keywords
- neoplasms, hematologic diseases, neoplasms by site, hematologic neoplasms, graft-versus-host disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Miami Sylvester Comprehensive Cancer Center
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 4 Apr 2025 (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 study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
Detailed description
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease.
Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care.
Participation in this study is expected to last up to 18 weeks after enrollment.
The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HORIZONS intervention | Experimental | Behavioral: HORIZONS InterventionParticipants randomized to HORIZONS plus usual care will complete the following: * Questionnaires at baseline, and weeks 10 and 18 * Receive the HORIZONS intervention from enrollment and for up to 8 weeks. HORIZONS is an 8-session multidisciplinary, patient-centered intervention that combines medical and psychosocial expertise to enhance self-management and quality of life. * Receive usual care as determined by their local clinicians |
| Minimally enhanced usual care | Active comparator | Behavioral: Minimally enhanced usual careParticipants randomized to usual care will complete the following * Questionnaires at baseline, and weeks 10 and 18 after enrollment * Receive a standardized booklet containing evidence-based information on chronic GVHD management and HCT survivorship recommendations as well as receive care as determined by their local oncologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥ 18 years) who have undergone allogeneic HCT
- Have moderate to severe cGVHD based on patient-report
- Have ability to participate in English or Spanish language group telehealth intervention.
Key exclusion criteria (3 listed)
- Patients with mild cGVHD based on their self-report.
- Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.
- Patients with active relapsed disease requiring therapy.
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 InterventionTherapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions | Behavioural | HORIZONS intervention |
| Minimally enhanced usual careReceiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations | Behavioural | Minimally enhanced usual care |
Primary outcome
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
Time frame: At 10 weeks post-enrollment
Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
3 secondary outcomes
Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
Time frame: At 10 weeks post enrollment
Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Anxiety)
Time frame: At 10 weeks post enrollment
Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale
Time frame: At 10 weeks post enrollment
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 24 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Areej El-Jawahri (ael-jawahri@mgb.org). The protocol and statistical analysis plan will be made available on Clinicaltrials.gov as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Areej El-Jawahri MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HORIZONS Intervention in people with Bone Marrow Transplant Complications and Graft-versus-Host Disease, run by Massachusetts General Hospital at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Lara Traeger PhD (304-284-3012, ltraeger@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire (time frame: At 10 weeks post-enrollment). 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 24 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.