The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Determine natural killer cell phenotype
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)
排除标准
- •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) as determined by treating provider
- •Chronic dizziness or vestibular disorders
- •History of recurrent falls (>2 in the prior year)
- •Grade 3 or greater neuropathy
- •Grade 3 or greater spinal fracture
研究组 & 干预措施
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.
干预措施: Tai Chi Easy (Other)
结局指标
主要结局
Determine natural killer cell phenotype
时间窗: Day 100
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity
时间窗: Day 100
Determine NK cell activity through peripheral blood analysis
Determine immune function
时间窗: Day 100
Determine immune function through peripheral blood analysis of immune factors
Determine natural killer cell phenotype
时间窗: Baseline
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
时间窗: Day 14
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine natural killer cell phenotype
时间窗: Day 30
Determine natural killer (NK) phenotype through peripheral blood analysis
Determine NK cell activity
时间窗: At baseline
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
时间窗: Day 14
Determine NK cell activity through peripheral blood analysis
Determine NK cell activity
时间窗: Day 30
Determine NK cell activity through peripheral blood analysis
Determine immune function
时间窗: At baseline
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
时间窗: Day 14
Determine immune function through peripheral blood analysis of immune factors
Determine immune function
时间窗: Day 30
Determine immune function through peripheral blood analysis of immune factors
次要结局
未报告次要终点