Mindfulness for Chronic Graft-Versus-Host Disease Symptoms

This study is testing a mindfulness program to help reduce symptoms in people with chronic graft-versus-host disease (cGVHD). cGVHD can happen after a stem cell transplant when donor cells attack your body, causing issues like stiffness, pain, anxiety, and poor sleep. The program involves weekly group mindfulness sessions, an individual session, and daily self-meditation using techniques like diaphragmatic breathing and body scans. Researchers want to see if this program is practical for patients to complete and if it helps improve their symptoms. You may be able to join if you are 18 or older, have moderate/severe cGVHD, and can read English. The study plans to enroll 17 participants.

Study design
This is an interventional study with a planned enrollment of 17 participants. It is a single-arm study, meaning all participants will receive the mindfulness intervention.
What's involved
You would attend weekly group mindfulness sessions for 8 weeks and one individual session. You are also recommended to practice self-meditation daily for at least 15 minutes for 8 weeks. Blood samples will be collected throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, compliance, is measured up to 8 weeks.

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NCT07733141

Mindfulness Intervention to Reduce Patient Reported Symptoms in Patients With Chronic Graft-Versus-Host Disease

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
City of Hope Medical Center
~17 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Biospecimen CollectionMindfulness RelaxationSurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance (feasibility)
Measured over Up to 8 weeks
Chronic Graft Versus Host Disease
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
1 sites across 1 states
California1
  • Amandeep Salhotra · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

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Eligibility criteria

Inclusion

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

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)
  • Compliance (feasibility)Up to 8 weeks

    Feasibility is defined as 12 or more of 15 evaluable participants meet compliance criteria. Compliance for each participant will be a binary endpoint (yes versus no). If a participant completes 5/7 group sessions, the practitioner/patient 1:1 session, and end of treatment assessments, compliance is defined as yes. Will be summarized using the percentage and 90% confidence intervals.