Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 5:29 AM
Study NCT ID:
NCT04760405
Status:
COMPLETED
Last Update Posted:
2024-08-16
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine natural killer cell phenotype', 'timeFrame': 'Baseline', 'description': 'Determine natural killer (NK) phenotype through peripheral blood analysis'}, {'measure': 'Determine natural killer cell phenotype', 'timeFrame': 'Day 14', 'description': 'Determine natural killer (NK) phenotype through peripheral blood analysis'}, {'measure': 'Determine natural killer cell phenotype', 'timeFrame': 'Day 30', 'description': 'Determine natural killer (NK) phenotype through peripheral blood analysis'}, {'measure': 'Determine natural killer cell phenotype', 'timeFrame': 'Day 100', 'description': 'Determine natural killer (NK) phenotype through peripheral blood analysis'}, {'measure': 'Determine NK cell activity', 'timeFrame': 'At baseline', 'description': 'Determine NK cell activity through peripheral blood analysis'}, {'measure': 'Determine NK cell activity', 'timeFrame': 'Day 14', 'description': 'Determine NK cell activity through peripheral blood analysis'}, {'measure': 'Determine NK cell activity', 'timeFrame': 'Day 30', 'description': 'Determine NK cell activity through peripheral blood analysis'}, {'measure': 'Determine NK cell activity', 'timeFrame': 'Day 100', 'description': 'Determine NK cell activity through peripheral blood analysis'}, {'measure': 'Determine immune function', 'timeFrame': 'At baseline', 'description': 'Determine immune function through peripheral blood analysis of immune factors'}, {'measure': 'Determine immune function', 'timeFrame': 'Day 14', 'description': 'Determine immune function through peripheral blood analysis of immune factors'}, {'measure': 'Determine immune function', 'timeFrame': 'Day 30', 'description': 'Determine immune function through peripheral blood analysis of immune factors'}, {'measure': 'Determine immune function', 'timeFrame': 'Day 100', 'description': 'Determine immune function through peripheral blood analysis of immune factors'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Stem cell transplant', 'Autologous stem cell transplantation', 'ASCT', 'Tai Chi'], 'conditions': ['Multiple Myeloma', 'Stem Cell Transplant Complications']}, 'descriptionModule': {'briefSummary': 'The current proposal aims to test the feasibility of immune function analysis for Tai Chi Easy (TCE) intervention in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT) with concurrent exploration of health related quality of life (HRQOL).', 'detailedDescription': 'The current proposal aims to test the feasibility of immune function analysis for TCE intervention in MM patients undergoing ASCT with concurrent exploration of HRQOL. The data obtained from this trial will provide supporting data for a future randomized clinical trial evaluating the impact of TCE on immune function (incidence of ASCT related infectious complications, natural killer cell phenotype and activity, and myeloma remission rate (clonal plasma cell % at day 100, minimal residual disease (MRD)), with the evaluation of efficacy on improving HRQOL during ASCT. Successful completion of this CROC project will provide necessary data to support future grant applications, in particular the feasibility of immunoassay evaluation of MM patients undergoing ASCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant\n2. 18 years or older\n3. English speaking\n4. General proficiency to read/write in English\n5. Able to attend TCE training session per study protocol\n6. ECOG performance status 0-1\n7. Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)\n\nExclusion Criteria:\n\n1. Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more\n2. Syncopal event in prior 60 days\n3. Concurrent major depressive disorder or anxiety disorder (DSMIV) as determined by treating provider\n4. Chronic dizziness or vestibular disorders\n5. History of recurrent falls (\\>2 in the prior year)\n6. Grade 3 or greater neuropathy\n7. Grade 3 or greater spinal fracture'}, 'identificationModule': {'nctId': 'NCT04760405', 'briefTitle': 'The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma', 'orgStudyIdInfo': {'id': '2011190017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi Easy Intervention', 'description': 'Tai Chi Easy: TCE is a standardized protocol used in several prior studies. TCE has been manualized and has a formal training program for instructors. The protocol is taught as a series of repeated and simple-to-learn movements. Patients will receive two 30-minute small group training sessions (Via Zoom) within 7 days of their scheduled transplant. After the training has been completed the participant will be provided with written (via manual) and electronic (DVD, MP3 file download) materials to continue with self-direct practice throughout the duration of the study.', 'interventionNames': ['Other: Tai Chi Easy']}], 'interventions': [{'name': 'Tai Chi Easy', 'type': 'OTHER', 'description': 'Patients will receive two 30-minute small group training sessions (Via Zoom) within 7 days of their scheduled transplant. After the training has been completed the participant will be provided with written (via manual) and electronic (DVD, MP3 file download) materials to continue with self-direct practice throughout the duration of the study.', 'armGroupLabels': ['Tai Chi Easy Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Krisstina Gowin, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}