Recruiting

Mindfulness Intervention

Sponsor:

City of Hope Medical Center

Code:

NCT07733141

Conditions

Chronic Graft Versus Host Disease

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Mindfulness Relaxation

Mindfulness Relaxation

Mindfulness Relaxation

Survey Administration

Study Details

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

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT07733141

Start date

Mar 1, 2027

Status verified date

Oct, 2026

Completion date

Apr 8, 2028

Anticipated

Primary completion date

Apr 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

17 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (mindfulness based intervention)

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Mindfulness Relaxation

Complete group mindfulness sessions

Mindfulness Relaxation

Complete individual mindfulness session

Mindfulness Relaxation

Complete daily self meditation

Survey Administration

Ancillary studies

Primary outcome measure

  • Compliance (feasibility) [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Amandeep Salhotra

626-218-2405asalhotra@coh.org

Principal Investigator:

Amandeep Salhotra

More Information

Sponsor

City of Hope Medical Center

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.