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

NCT ID: NCT04760405

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2023-11-28

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.

Conditions

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Multiple Myeloma Stem Cell Transplant Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tai Chi Easy Intervention

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.

Group Type EXPERIMENTAL

Tai Chi Easy

Intervention Type OTHER

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

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Tai Chi Easy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Krisstina Gowin, DO

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2011190017

Identifier Type: -

Identifier Source: org_study_id

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