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NCT Number: NCT06910969

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.

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Key information

Conditions

Bone Marrow Transplant Complications Graft vs Host Disease Graft-Versus-Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HORIZONS Intervention

Behavioral

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

Minimally Enhanced Usual Care

Behavioral

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

Primary outcomes

  1. Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

    Time frame: 10 weeks

    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

Secondary outcomes

  1. Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire

    Time frame: Up to 18 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

  2. Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)

    Time frame: Up to 18 weeks post enrollment

    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

  3. Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)

    Time frame: Up to 18 weeks post enrollment

    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.

  4. Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale

    Time frame: Up to 18 weeks post enrollment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Areej El-Jawahri MD

CONTACT

[email protected]

617-721-4000

Lara Traeger PhD

CONTACT

[email protected]

304-284-3012

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Miami Sylvester Comprehensive Cancer Center

Registry information

Official study title

Multi-Site Randomized Controlled Trial of A Multidisciplinary Intervention for Adults With Chronic Graft Versus Host Disease

Acronym: HORIZONS

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Apr 4, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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