Recruiting

HORIZONS

Sponsor:

Massachusetts General Hospital

Code:

NCT06910969

Conditions

Bone Marrow Transplant Complications

Graft-versus-Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HORIZONS Intervention

Minimally enhanced usual care

Study Details

Brief 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, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.

Conditions

Bone Marrow Transplant Complications

Graft-versus-Host Disease

Study ID

NCT06910969

Start date

Aug 13, 2025

Status verified date

Mar, 2026

Completion date

Feb 1, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: HORIZONS intervention

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

active comparator: Minimally enhanced usual care

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

Interventions

HORIZONS Intervention

Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions

Minimally enhanced usual care

Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations

Primary outcome measure

  • Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Lara Traeger PhD

304-284-3012ltraeger@miami.edu

Areej El-Jawahri MD

617-721-4000ael-jawahri@mgb.org

Locations

University of Miami Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Lara Traeger, PhD

305-243-5302ltraeger@miami.edu

Principal Investigator:

Lara Traeger, PhD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Areej El-Jawahri

617-724-4000ael-jawahri@mgb.org

Principal Investigator:

Areej El-Jawahri, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • neoplasms
  • hematologic diseases
  • neoplasms by site
  • hematologic neoplasms
  • graft-versus-host disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-03.