Multiple Myeloma, Stem Cell Transplant Complications
Conditions
Keywords
Multiple Myeloma, Stem cell transplant, Autologous stem cell transplantation, ASCT, Tai Chi
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).
Detailed 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.
Interventions
OTHERTai 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.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine natural killer cell phenotype | Baseline | Determine natural killer (NK) phenotype through peripheral blood analysis |
| Determine NK cell activity | At baseline | Determine NK cell activity through peripheral blood analysis |
| Determine immune function | At baseline | Determine immune function through peripheral blood analysis of immune factors |
Countries
United States
Outcome results
None listed