Multidisciplinary Intervention In Chronic GVHD (NCT04479995) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multidisciplinary Intervention In Chronic GVHD
United States80 participantsStarted 2020-08-02
Plain-language 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 transplant and developed graft versus-host disease (GVHD).
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Enrollment
Timeframe: Baseline (pre-randomization) to 8 week follow up
2
Rate of adherence
Timeframe: Baseline (pre-randomization) to 8 week follow up
3
Rate of retention
Timeframe: Baseline (pre-randomization) to 8 week follow up