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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).
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:
The MGH BMT Survivorship Program is supporting this research study by providing funding for this project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Horizon Program | Behavioral | Telehealth videoconferencing sessions and questionnaires. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Enrollment | Feasibility will be demonstrated if ≥50% eligible participants enroll | Baseline (pre-randomization) to 8 week follow up |
| Rate of adherence | Feasibility will be demonstrated if 80% complete ≥4 of 8 sessions | Baseline (pre-randomization) to 8 week follow up |
| Rate of retention | Feasibility will be demonstrated if 80% of participants remain in study | Baseline (pre-randomization) to 8 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (pre-randomization) up to 16 week follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Areej El-Jawahri, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39814942 | Derived | 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. |
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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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Usual Care |
| Behavioral |
Standard medical visits with additional paper or electronic booklet. |
|
| 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). | 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). | 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). | 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). | 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). | 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). | Baseline (pre-randomization) up to 16 week follow up |