The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma

Conditions
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Multiple Myeloma, Stem Cell Transplant Complications

Intervention / Treatment
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* Other: Tai Chi Easy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant 18 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 Exclusion Criteria: 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) Chronic dizziness or vestibular disorders History of recurrent falls (>2 in the prior year) Grade 3 or greater neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi Easy Intervention<br>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. | Other: Tai Chi Easy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi