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Multidisciplinary Intervention for Adults With Chronic Graft-versus-host Disease

ConditionsBone Marrow Transplant ComplicationsGraft-versus-Host Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: HORIZONS interventionExperimental treatment 1 intervention
Group B: Minimally enhanced usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

University of Miami Sylvester Comprehensive Cancer Center

Collaborator

Source ClinicalTrials.gov
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