Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
1 other identifier
interventional
29
1 country
1
Brief Summary
Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-myeloma
Started Feb 2015
Typical duration for not_applicable multiple-myeloma
1 active site
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
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedApril 19, 2019
April 1, 2019
3.7 years
October 22, 2014
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of life
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series
30 days
Secondary Outcomes (2)
Time to engraftment
15 days
Rate of febrile neutropenia
30 days
Study Arms (2)
Tai Chi
EXPERIMENTALGroup randomized to participate in Tai Chi intervention
Educational
ACTIVE COMPARATORGroup randomized to participate in educational intervention
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Multiple myeloma \> 18 years of age or greater
- English speaking
- General proficiency to read and write in English
- Able to attend training session per study protocol
- ECOG performance status 0-1
You may not qualify if:
- Currently performs Tai Chi, Qi Gong, or Yoga at least once weekly or more
- Syncopal event in prior 60 days
- Current Grade 3 or \> neuropathy
- Concurrent major depressive disorder or anxiety disorder (DSMIV)
- Chronic Dizziness and/or vestibular disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Arizona State Universitycollaborator
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nandita Khera, MD, MPH
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2014
First Posted
October 24, 2014
Study Start
February 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
April 19, 2019
Record last verified: 2019-04