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

University of Arizona

Status: Completed

Conditions: Multiple Myeloma; Stem Cell Transplant Complications

Treatments: Other: Tai Chi Easy

Study type: Interventional

Funder types: Other

Identifiers

NCT04760405

2011190017

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant
2. 18 years or older
3. English speaking
4. General proficiency to read/write in English
5. Able to attend TCE training session per study protocol
6. ECOG performance status 0-1
7. Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)

Exclusion criteria

1. Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more
2. Syncopal event in prior 60 days
3. Concurrent major depressive disorder or anxiety disorder (DSMIV) as determined by treating provider
4. Chronic dizziness or vestibular disorders
5. History of recurrent falls (>2 in the prior year)
6. Grade 3 or greater neuropathy
7. Grade 3 or greater spinal fracture

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Tai Chi Easy Intervention

Experimental group

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.

Treatment:

Other: Tai Chi Easy