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

NCT07733141 | Not Yet Recruiting DMC

• 3 other identifiers: 25870NCI-2026-04201P30CA033572
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Graft Versus Host Disease; Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Compliance (feasibility)

  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.

  Up to 8 weeks

Secondary Outcomes (4)

• Reason for not starting study activities after signing consent

  Up to 8 weeks

• Feasibility of daily meditation in patients with a diagnosis of cGVHD

  Up to 8 weeks

• Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS

  From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks

• Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria

  From baseline to completion of MBI program, up to 8 weeks

Study Arms (1)

Supportive care (mindfulness based intervention)

EXPERIMENTAL

Patients complete group sessions QW, on weeks 1-4, over 40 minutes, and on weeks 6-8, over 60 minutes, and an individual session, over 60 minutes, on week 5. Sessions consist of instruction on diaphragmatic breathing, body scan, visualization, and individual mediation practice. Patients are recommended to complete self mediation daily for at least 15 minutes, for 8 weeks. Patients undergo blood sample collection throughout the study.

Procedure: Biospecimen Collection; Behavioral: Mindfulness Relaxation; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Supportive care (mindfulness based intervention)

Mindfulness Relaxation BEHAVIORAL

Complete group mindfulness sessions

Also known as: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction

Supportive care (mindfulness based intervention)

Survey Administration OTHER

Ancillary studies

Supportive care (mindfulness based intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Specimen Handling; Mindfulness; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amandeep Salhotra

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)