Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versu… (NCT07733141) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease
United States17 participantsStarted 2027-03-01
Plain-language summary
This clinical trial tests a mindfulness intervention, consisting of group sessions and an individual session, using mindfulness based stress reduction techniques, to reduce patient reported symptoms for patients with chronic graft versus host disease (cGVHD). In patients undergoing allogeneic stem cell transplant, sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). In cGVHD patients may encounter stiffness, itching, joint and muscle pain, oral cavity pain, itchy eyes, shortness of breath, depression, anxiety, and poor sleep resulting in a significant impact on patients' quality of life. Mindfulness interventions use meditation practices with elements of psychology to improve emotional regulation, resilience and acceptance based coping. This mindfulness based intervention may reduce patient reported symptoms in patients with cGVHD.
Who can participate
Age range
18 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:
* Documented informed consent of the participant and/or legally authorized representative
* Willingness to participate in the study
* Willingness to attend in-person or virtual group sessions
* Ability to read and understand English (required for protocol therapy and planned survey)
* Age: ≥ 18 years
* Confirmed diagnosis of moderate/severe chronic graft-versus-host disease by National Institute of Health (NIH) criteria
* Karnofsky performance status ≥ 80
Exclusion Criteria:
* Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)/ mindfulness-based stress reduction (MBSR)
* An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation
* Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)
* Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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.
1This trial is listed as 'not yet recruiting' — do you know when it might open to enrollment, and should I be doing anything now to prepare in case I want to be considered later?
2Since this is a mindfulness intervention study, not a drug trial, and the main thing being measured is whether patients can actually stick with the program rather than whether it improves outcomes, what does that mean for what I might personally get out of participating?
3Chronic graft-versus-host disease can be really demanding to manage — how would adding a mindfulness program fit into my current treatment schedule, and is there any concern it could interfere with what I'm already doing?
4Because this study is listed as Phase NA, meaning it's more of a behavioral feasibility study than a traditional drug trial, should I be thinking about this as a complement to my existing cGVHD treatment rather than a replacement for anything?
5Are there other ways I could access mindfulness or symptom-management support for my cGVHD right now, without waiting for this trial to open, in case the timing doesn't work out for me?
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.