Mindfulness program to help with symptoms in chronic graft-versus-host disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial tests an 8-week mindfulness-based intervention (MBI) that includes weekly group sessions and a 1:1 session, plus a daily self-meditation goal, in adults with chronic GVHD. The study will measure feasibility (participation and adherence) and collect preliminary signals of efficacy, along with biospecimens and survey data. Participants attend in-person or virtual sessions and complete daily meditation as recommended. Blood samples are collected throughout the study to monitor biomarkers. The trial is conducted at City of Hope Medical Center with collaboration from the NCI.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Amandeep Salhotra — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.