An interventional study of HORIZONS Intervention and Minimally enhanced usual care in Bone Marrow Transplant Complications and Graft-versus-Host Disease, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Supportive care
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.
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.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
This study's planned enrollment of 350 is above the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: HORIZONS Intervention
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
Behavioral: Minimally enhanced usual care
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
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
Time frame: At 10 weeks post-enrollment
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
Time frame: 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.
Time frame: 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
Time frame: At 10 weeks post enrollment
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2029, 45 months after the start.
Of 32 interventional studies with no phase under Graft vs Host Disease, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 45 months is close to that.
How these figures are worked out, and which studies are left out of them.
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