[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06910969":3,"trial-entities:NCT06910969":122,"trial-summary:NCT06910969":126},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":76,"locations":79,"central_contacts":111,"overall_officials":118,"references":120,"see_also_links":121},"NCT06910969","24-651","Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease","Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease","RECRUITING","2030-02-01","2026-03","2026-03-03","2025-08-13","Massachusetts General Hospital","OTHER",true,"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.\n\nParticipants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care.\n\nParticipation in this study is expected to last up to 18 weeks after enrollment.\n\nThe 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.",[19,20],"Bone Marrow Transplant Complications","Graft-versus-Host Disease",[22,23,24,25,26],"neoplasms","hematologic diseases","neoplasms by site","hematologic neoplasms","graft-versus-host disease","INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},350,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","HORIZONS Intervention","Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions",[40],"HORIZONS intervention",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Minimally enhanced usual care","Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations",[42],[46],{"measure":47,"description":48,"timeFrame":49},"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","10 weeks",[51,53,56,59],{"measure":47,"description":48,"timeFrame":52},"Up to 18 weeks post enrollment",{"measure":54,"description":55,"timeFrame":52},"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",{"measure":57,"description":58,"timeFrame":52},"Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)","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 depression symptoms.",{"measure":60,"description":61,"timeFrame":52},"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","ALL","18 Years",null,false,{"inclusion":67,"exclusion":71,"raw_text":75},[68,69,70],"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.",[72,73,74],"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.","Inclusion Criteria:\n\n* Adult patients (≥ 18 years) who have undergone allogeneic HCT\n* Have moderate to severe cGVHD based on patient-report\n* Have ability to participate in English or Spanish language group telehealth intervention.\n\nExclusion Criteria:\n\n* Patients with mild cGVHD based on their self-report.\n* Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent.\n* Patients with active relapsed disease requiring therapy.",[77,78],"ADULT","OLDER_ADULT",[80,97],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":94},"University of Miami Sylvester Comprehensive Cancer Center","Miami","Florida","33136","United States",[87,92],{"name":88,"role":89,"phone":90,"email":91},"Lara Traeger, PhD","CONTACT","305-243-5302","ltraeger@miami.edu",{"name":88,"role":93},"PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},25.77427,-80.19366,{"facility":13,"status":8,"city":98,"state":99,"zip":100,"country":85,"contacts":101,"geoPoint":108},"Boston","Massachusetts","02114",[102,106],{"name":103,"role":89,"phone":104,"email":105},"Areej El-Jawahri","617-724-4000","ael-jawahri@mgb.org",{"name":107,"role":93},"Areej El-Jawahri, MD",{"lat":109,"lon":110},42.35843,-71.05977,[112,115],{"name":113,"role":89,"phone":114,"email":91},"Lara Traeger PhD","304-284-3012",{"name":116,"role":89,"phone":117,"email":105},"Areej El-Jawahri MD","617-721-4000",[119],{"name":116,"affiliation":13,"role":93},[],[],{"nct_id":4,"conditions":123,"biomarkers":125},[124],"Graft Versus Host Disease",[],{"nct_id":4,"found":15,"summary":127,"prompt_version":137},{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This is a randomized clinical trial involving about 350 adult participants. You would be randomly assigned to one of two groups: the HORIZONS intervention or a group receiving a booklet with information.","completed","Multidisciplinary Intervention for Chronic Graft-versus-Host Disease","This study is testing a program called HORIZONS, which is a group-based telehealth (online video calls) intervention with therapists, to see if it improves the quality of life for adults living with chronic graft-versus-host disease (cGVHD). cGVHD is a complication that can happen after a bone marrow transplant. You would either receive the HORIZONS program, which involves 8 sessions, or a standardized booklet with information on managing cGVHD. The main goal is to see if HORIZONS improves your quality of life after 10 weeks. We are looking for about 350 adults who have had an allogeneic hematopoietic stem cell transplant (a type of bone marrow transplant) and have moderate to severe cGVHD. You must be able to participate in English or Spanish. The study aims to understand how well HORIZONS works and what helps or hinders its use.","Your quality of life will be measured at 10 weeks after joining the study.",138,"Participation in this study is expected to last up to 18 weeks after you join. The HORIZONS intervention involves 8 sessions.","Not stated in the trial record.",[],"v2"]