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临床试验/NCT02274519
NCT02274519已完成不适用

Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
29
试验地点
2
主要终点
Quality of life

研究概览

简要总结

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?

详细描述

All patients with Multiple Myeloma seen at Mayo Clinic Arizona who are undergoing evaluation for autologous stem cell transplant will be identified for potential candidacy by BMT transplant coordinator staff and referred to CRC study staff for final screen of candidacy over a period of 12 months. If eligible, ≤ 30 days prior to transplant CRC study staff will meet with patient for consent and undergo 1:1 randomization to Tai Chi versus educational control arm (N: 70). No earlier than 7 days prior to transplant all patients will attend a 1 hour session consisting of Tai Chi techniques or receive educational materials depending on the patients prior randomization and will start their intervention, subject diary and support materials will be provided. Patients will be asked to perform 30 minutes of intervention daily (Tai Chi versus educational control) and document minutes and quality of practice in their subject diary. On day 1 of autologous stem cell transplant CRC staff will administer the baseline questionnaires (NIH PROMIS Short form questionnaires for pain, depression, anxiety, social isolation, and sleep). Patients will continue their intervention (Tai chi versus educational control) daily throughout autologous stem cell transplant and record intervention fidelity in patient diary. On day 14 of transplant the NIH PROMIS questionnaires, perceived benefit questionnaire, and the meditative movement inventory for the Tai chi group only will be collected. Data collection for secondary outcomes including time to engraftment, incidence of febrile neutropenia, days of hospitalization, etc will be also gathered. Patients will continue intervention through transplant day 30 (+/- 5 days) at which time, CRC staff will collect subject diary, administer NIH PROMIS questionnaires, and a perceived benefit questionnaire. Adherence reminders will be executed once per week by CRC staff from date of initiation of intervention to completion of study.

The intervention to be tested, TCEasy, is a standardized protocol that was developed by Dr. Roger Jahnke and has been used in several prior studies including a recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors (U01 AT002706-03: PI Linda Larkey, PhD, Arizona State University, primary outcome paper currently under review). Participants will be given a written instruction manual for the Tai Chi exercises to refer to after training has been administered.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Tai Chi

Experimental

Group randomized to participate in Tai Chi intervention

干预措施: Tai Chi (Other)

Educational

Active Comparator

Group randomized to participate in educational intervention

干预措施: Education (Other)

结局指标

主要结局

Quality of life

时间窗: 30 days

Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series

次要结局

  • Time to engraftment(15 days)
  • Rate of febrile neutropenia(30 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nandita Khera

Principal Investigator

Mayo Clinic

研究点 (2)

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