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

Pilot Feasibility Study of Mindfulness-Based Intervention in Patients With Chronic Graft-Versus-Host Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks."
  • "Patients undergo blood sample collection throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether mindfulness practices, such as meditation, can reduce symptoms of chronic graft-versus-host disease (cGVHD). It is for adults with moderate or severe cGVHD, a condition in which donor cells attack the body after a stem cell transplant. The study includes group sessions and one individual session.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You or your legal representative must give written consent to join.
  • You must be willing to take part in the study.
  • You must be willing to attend group sessions in person or online.
  • You must be able to read and understand English.
  • You must be age 18 or older.
  • You must have confirmed moderate or severe cGVHD based on National Institutes of Health rules.
  • You must have a Karnofsky score of at least 80, meaning you can do normal activities with some effort.

Who can't join

  • You have attended four or more sessions of mindfulness-based talk therapy or mindfulness-based stress reduction.
  • Your cGVHD medicine dose increased, or you added a new cGVHD medicine, within 4 weeks before the starting study visit.
  • The study leader finds that you have a severe mental health condition, such as loss of touch with reality or thoughts of suicide.
  • You have cancer, an illness where the immune system attacks your body, a long-term infection, or another long-term illness causing swelling that the study leader thinks could affect the results.
  • The study leader thinks you may not be able to follow all study steps, including because of travel or scheduling problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

CA