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Active, Not Recruiting

NCT Number: NCT04479995

Multidisciplinary Intervention In Chronic GVHD

This research is being done to evaluate the feasibility and efficacy of a multidisciplinary, patient-centered intervention, Horizons Program, versus minimally enhanced standard care to improve quality of life, symptom burden and psychological distress of adults who received an allogeneic hematopoietic stem cell transplant and developed graft versus-host disease (GVHD).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stem Cell Transplant Complications Coping Skills Graft vs Host Disease Immune System Diseases Quality of Life

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

This randomized research study is being conducted to see if the Horizons Program compared to usual care is manageable and effective at improving understanding of chronic GVHD and treatment, coping, and quality of life.

Randomization means that participants will be put into one of two groups by chance:

  • Horizons Program

--Individuals who receive the Horizons Program will attend 8 weekly 90-minute group sessions using a secure TeleHealth videoconferencing system

  • Usual care --Individuals who receive usual care will also receive an educational booklet.

The research study procedures include:

  • screening for eligibility
  • a brief test of videoconferencing software
  • completion of three study assessments (after signing consent but before randomization and at 8 weeks and 16 weeks after the start of the Horizons Program)
  • Individuals who receive usual care will also receive an educational booklet. It is anticipated 80 people will take part in this research study.

The MGH BMT Survivorship Program is supporting this research study by providing funding for this project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients (≥ 21 years) who underwent allogeneic HCT
  • have moderate to severe chronic GVHD
  • are currently receiving their care at the MGH Blood and Marrow Transplant Clinic
  • have the ability to participate in an English language group intervention

Exclusion criteria

  • Patients with comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
  • Vulnerable patients, defined here as prisoners and pregnant women, will not be included in the intervention

Treatment and study plan

Horizon Program

Behavioral

Telehealth videoconferencing sessions and questionnaires.

Usual Care

Behavioral

Standard medical visits with additional paper or electronic booklet.

Primary outcomes

  1. Rate of Enrollment

    Time frame: Baseline (pre-randomization) to 8 week follow up

    Feasibility will be demonstrated if ≥50% eligible participants enroll

  2. Rate of adherence

    Time frame: Baseline (pre-randomization) to 8 week follow up

    Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions

  3. Rate of retention

    Time frame: Baseline (pre-randomization) to 8 week follow up

    Feasibility will be demonstrated if 80% of participants remain in study

Secondary outcomes

  1. Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in quality of life between study groups (FACT-BMT score range 0-164, with higher scores indicating better quality of life).

  2. Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in symptom burden between study groups (Lee cGVHD score range 0-56, with higher scores indicating worse symptom burden).

  3. Psychological Distress: Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in psychological distress between study groups (HADS score range 0-21, with higher scores indicating greater distress).

  4. Medical Adherence: Medication Adherence Report Scale (MARS-5)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in medical adherence self management between study groups (MARS-5 score range 5-25, with higher scores indicating greater adherence).

  5. Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in social support self management between study groups (MOS SSS score range 0-100, with higher scores indicating greater support).

  6. Self-Efficacy: Cancer Self-Efficacy Scale (CASE)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    We will use linear mixed models to investigate longitudinal differences in cancer self-efficacy between study groups (CASE score range 0-170, with higher scores indicating greater self-efficacy).

  7. Coping Skills: Measure of Current Status (MOCS)

    Time frame: Baseline (pre-randomization) up to 16 week follow up

    Using to compare Coping Skills self management target between study groups

    We will use linear mixed models to investigate longitudinal differences in coping skills between study groups (CASE score range 0-52, with higher scores indicating greater coping skill).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD

Important dates

Study start
2020
Primary completion
2022
Study completion
2027
First posted
Jul 21, 2020
Registry last updated
Jan 20, 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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