[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733141":3,"trial-entities:NCT07733141":129,"trial-summary:NCT07733141":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":64,"secondary_outcomes":69,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":104,"locations":107,"central_contacts":124,"overall_officials":125,"references":127,"see_also_links":128},"NCT07733141","25870","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","NOT_YET_RECRUITING","2029-03-01","2026-07","2026-07-29","2027-03-01","City of Hope Medical Center","OTHER",true,"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.","PRIMARY OBJECTIVE:\n\nI. Assess the feasibility of an 8-week mindfulness-based intervention (MBI) program consisting of weekly group sessions and a practitioner\u002Fpatient 1:1 session in patients with a diagnosis of chronic graft-versus-host disease (cGVHD).\n\nSECONDARY OBJECTIVES:\n\nI. Determine the number of patients who withdraw consent before starting group sessions or do not attend any of the planned group sessions.\n\nII. Assess the feasibility of daily self-meditation in patients with a diagnosis of cGVHD.\n\nIII. Estimate the preliminary efficacy of the MBI program in patients with cGVHD.\n\nEXPLORATORY OBJECTIVE:\n\nI. Examine potential associations between the MBI program and the following at baseline, Week 4, and at completion of the MBI program.\n\nOUTLINE:\n\nPatients complete group sessions once weekly (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.",[19,20,21],"Chronic Graft Versus Host Disease","Hematopoietic and Lymphatic System Neoplasm","Malignant Solid Neoplasm",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},17,"ESTIMATED",[31,42,52,56,60],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[36],"Supportive care (mindfulness based intervention)",[38,39,40,41],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","Mindfulness Relaxation","Complete group mindfulness sessions",[36],[48,49,50,51],"MBSR","Mindful Meditation","Mindfulness Meditation","Mindfulness-Based Stress Reduction",{"type":43,"name":44,"description":53,"armGroupLabels":54,"otherNames":55},"Complete individual mindfulness session",[36],[48,49,50,51],{"type":43,"name":44,"description":57,"armGroupLabels":58,"otherNames":59},"Complete daily self meditation",[36],[48,49,50,51],{"type":14,"name":61,"description":62,"armGroupLabels":63},"Survey Administration","Ancillary studies",[36],[65],{"measure":66,"description":67,"timeFrame":68},"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\u002F7 group sessions, the practitioner\u002Fpatient 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",[70,73,76,80],{"measure":71,"description":72,"timeFrame":68},"Reason for not starting study activities after signing consent","For participants who withdraw consent before starting group sessions or do not attend any of the planned group sessions, the reason for not starting study activities after signing consent will be recorded for each patient",{"measure":74,"description":75,"timeFrame":68},"Feasibility of daily meditation in patients with a diagnosis of cGVHD","Feasibility of daily meditation will be assessed weekly and will be defined as 4\u002F7 days per week in which the participant logged at least 15 minutes of individual meditation",{"measure":77,"description":78,"timeFrame":79},"Decrease of > 5 points on the 7-day Modified Lee Chronic Graft Versus Host Disease Symptom Scale (MLSS","Participants will self-report the level of distress they experienced in the previous week for each of the 28-items on a scale of 0 to 4, with 0 representing \"not at all\", 1 \"slightly\", 2 \"moderately\", 3 \"quite a bit\", and 4 \"extremely\". Items will be added to create a total score, which can range from 0 to 100, with a higher score indicating a higher overall symptom burden","From baseline to completion of mindfulness based intervention (MBI) program, up to 8 weeks",{"measure":81,"description":82,"timeFrame":83},"Decrease in cGVHD severity stage per 2014 NIH consensus cGVHD grading criteria","Decrease of one full organ stage (e.g., Stage 1 to Stage 2), or a clear functional change like a 2-point P-ROM score shift per 2014 NIH consensus cGVHD grading criteria","From baseline to completion of MBI program, up to 8 weeks","ALL","18 Years",null,false,{"inclusion":89,"exclusion":97,"raw_text":103},[90,91,92,93,94,95,96],"Documented informed consent of the participant and\u002For 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\u002Fsevere chronic graft-versus-host disease by National Institute of Health (NIH) criteria","Karnofsky performance status ≥ 80",[98,99,100,101,102],"Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)\u002F 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\u002Flogistics)","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Willingness to participate in the study\n* Willingness to attend in-person or virtual group sessions\n* Ability to read and understand English (required for protocol therapy and planned survey)\n* Age: ≥ 18 years\n* Confirmed diagnosis of moderate\u002Fsevere chronic graft-versus-host disease by National Institute of Health (NIH) criteria\n* Karnofsky performance status ≥ 80\n\nExclusion Criteria:\n\n* Previous participation in four or more sessions of mindfulness-based cognitive therapy (MBCT)\u002F mindfulness-based stress reduction (MBSR)\n* An increase in anti-cGvHD medication (increased dosage or addition of a new medication) within 4 weeks prior to baseline evaluation\n* Severe psychiatric comorbidities (active psychosis, suicidal ideation) as determined by primary investigator (PI)\n* Concurrent malignancy, autoimmune disease, chronic infections, or other chronic inflammatory illness that might confound the results as determined by the PI\n* 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\u002Flogistics)",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":13,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":121},"Duarte","California","91010","United States",[114,119],{"name":115,"role":116,"phone":117,"email":118},"Amandeep Salhotra","CONTACT","626-218-2405","asalhotra@coh.org",{"name":115,"role":120},"PRINCIPAL_INVESTIGATOR",{"lat":122,"lon":123},34.13945,-117.97729,[],[126],{"name":115,"affiliation":13,"role":120},[],[],{"nct_id":4,"conditions":130,"biomarkers":131},[19],[],{"nct_id":4,"found":15,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This is an interventional study with a planned enrollment of 17 participants. It is a single-arm study, meaning all participants will receive the mindfulness intervention.","completed","Mindfulness for Chronic Graft-Versus-Host Disease Symptoms","This study is testing a mindfulness program to help reduce symptoms in people with chronic graft-versus-host disease (cGVHD). cGVHD can happen after a stem cell transplant when donor cells attack your body, causing issues like stiffness, pain, anxiety, and poor sleep. The program involves weekly group mindfulness sessions, an individual session, and daily self-meditation using techniques like diaphragmatic breathing and body scans. Researchers want to see if this program is practical for patients to complete and if it helps improve their symptoms. You may be able to join if you are 18 or older, have moderate\u002Fsevere cGVHD, and can read English. The study plans to enroll 17 participants.","The primary endpoint, compliance, is measured up to 8 weeks.",108,"You would attend weekly group mindfulness sessions for 8 weeks and one individual session. You are also recommended to practice self-meditation daily for at least 15 minutes for 8 weeks. Blood samples will be collected throughout the study.","Not stated in the trial record.",[],"v2"]