Stem Cell Transplant ComplicationsNCT04479995
Multidisciplinary Intervention In Chronic GVHD
A study testing Horizon Program in people with Stem Cell Transplant Complications and Graft Vs Host Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stem Cell Transplant Complications, Graft Vs Host Disease, Coping Skills
- What is being tested?
- Horizon Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2020to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (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).
Read the detailed description
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.
- Being tested
- Horizon Program, Usual Care
- Keywords
- Stem Cell Transplant Complications, Graft Vs Host Disease, Coping Skills, Quality of Life
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizon ProgramBehavioural
Telehealth videoconferencing sessions and questionnaires.
Usual CareBehavioural
Standard medical visits with additional paper or electronic booklet.
| Study group | Role | What they receive |
|---|---|---|
| Horizon Program | Experimental | Eight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes.
Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions Receives: Behavioral: Horizon Program |
| Usual Care | Experimental | Standard medical visits to address chronic GVHD, with an additional standardized booklet, in electronic or paper format, containing information on the management of chronic GVHD and stem cell transplant survivorship recommendations.
Questionnaire assessment at 8 weeks and 16 weeks after Horizons Program group starts Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Enrollment
Feasibility will be demonstrated if ≥50% eligible participants enroll
Measured: Baseline (pre-randomization) to 8 week follow up
Rate of adherence
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
Measured: Baseline (pre-randomization) to 8 week follow up
Rate of retention
Feasibility will be demonstrated if 80% of participants remain in study
Measured: Baseline (pre-randomization) to 8 week follow up
Secondary outcomes (7)
Quality of life (QOL): Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Psychological Distress: Hospital Anxiety and Depression Scale (HADS)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Medical Adherence: Medication Adherence Report Scale (MARS-5)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Self-Efficacy: Cancer Self-Efficacy Scale (CASE)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Coping Skills: Measure of Current Status (MOCS)
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).
Measured: Baseline (pre-randomization) up to 16 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start2 Aug 2020
- Primary completion1 Apr 2022
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Areej El-Jawahri, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479995
- Sponsor's protocol ID
- 19-772
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Centracchio JA, Yang DG, Jagielo AD, Greer JA, El-Jawahri A, Traeger L, Nelson AM. "They knew the same struggles": perceptions of a group coping skills intervention in patients with chronic graft-versus-host disease. Support Care Cancer. 2025 Jan 16;33(2):102. doi: 10.1007/s00520-025-09153-x.
PubMed 39814942
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Intervention to Promote Medical Adherence and Coping in Patients With Moderate to Severe Chronic Graft-Versus-Host Disease (GVHD
- ClinicalTrials.gov ID
- NCT04479995
- Acronym / sponsor ID
- 19-772
- Keywords
- Stem Cell Transplant Complications, Graft Vs Host Disease, Coping Skills, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Horizon Program | Experimental | Behavioral: Horizon ProgramEight weekly, audio recorded telehealth videoconferencing sessions. Sessions are 90 minutes. Questionnaire assessments at 8 and 16 weeks after end of videoconferencing sessions |
| Usual Care | Experimental | Behavioral: Usual CareStandard medical visits to address chronic GVHD, with an additional standardized booklet, in electronic or paper format, containing information on the management of chronic GVHD and stem cell transplant survivorship recommendations. Questionnaire assessment at 8 weeks and 16 weeks after Horizons Program group starts |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horizon ProgramTelehealth videoconferencing sessions and questionnaires. | Behavioural | Horizon Program |
| Usual CareStandard medical visits with additional paper or electronic booklet. | Behavioural | Usual Care |
Primary outcome
Rate of Enrollment
Time frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if ≥50% eligible participants enroll
Rate of adherence
Time frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions
Rate of retention
Time frame: Baseline (pre-randomization) to 8 week follow up
Feasibility will be demonstrated if 80% of participants remain in study
7 secondary outcomes
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
Symptom Burden: Lee Chronic Graft-Versus-Host Disease Symptom Scale (Lee cGVHD)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Psychological Distress: Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Medical Adherence: Medication Adherence Report Scale (MARS-5)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Social Support: Medical Outcomes Study Social Support Survey (MOS SSS)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Self-Efficacy: Cancer Self-Efficacy Scale (CASE)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Coping Skills: Measure of Current Status (MOCS)
Time frame: Baseline (pre-randomization) up to 16 week follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 39814942Centracchio JA, Yang DG, Jagielo AD, Greer JA, El-Jawahri A, Traeger L, Nelson AM. "They knew the same struggles": perceptions of a group coping skills intervention in patients with chronic graft-versus-host disease. Support Care Cancer. 2025 Jan 16;33(2):102. doi: 10.1007/s00520-025-09153-x.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areej El-Jawahri, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizon Program in people with Stem Cell Transplant Complications and Graft Vs Host Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Enrollment (time frame: Baseline (pre-randomization) to 8 week follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.