The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
1 other identifier
interventional
12
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started Mar 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
March 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2023
CompletedAugust 16, 2024
August 1, 2024
2.7 years
January 15, 2021
August 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Baseline
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 14
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 30
Determine natural killer cell phenotype
Determine natural killer (NK) phenotype through peripheral blood analysis
Day 100
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
At baseline
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Day 14
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Day 30
Determine NK cell activity
Determine NK cell activity through peripheral blood analysis
Day 100
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
At baseline
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Day 14
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Day 30
Determine immune function
Determine immune function through peripheral blood analysis of immune factors
Day 100
Study Arms (1)
Tai Chi Easy Intervention
EXPERIMENTALTai 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant
- years or older
- English speaking
- General proficiency to read/write in English
- Able to attend TCE training session per study protocol
- ECOG performance status 0-1
- Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)
You may not qualify if:
- Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more
- Syncopal event in prior 60 days
- Concurrent major depressive disorder or anxiety disorder (DSMIV) as determined by treating provider
- Chronic dizziness or vestibular disorders
- History of recurrent falls (\>2 in the prior year)
- Grade 3 or greater neuropathy
- Grade 3 or greater spinal fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Arizona
Tucson, Arizona, 85724, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krisstina Gowin, DO
University of Arizona
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
January 15, 2021
First Posted
February 18, 2021
Study Start
March 11, 2021
Primary Completion
November 28, 2023
Study Completion
November 28, 2023
Last Updated
August 16, 2024
Record last verified: 2024-08