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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Mindfulness Relaxation
  • Mindfulness Relaxation
  • Mindfulness Relaxation
  • Survey Administration

Treatment groups

17 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator