Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
2018年3月8日 更新者：Mayo Clinic
Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy.
Tai Chi Easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.
GROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
After completion of study, patients are followed up at 2 months.
研究类型
介入性
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
- Self-report of >= 4 on the Peripheral Neuropathy Question
Exclusion Criteria:
- Recurrence of cancer or other active cancer
- Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
- Uncontrolled diabetes, untreated hypothyroidism
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group I (Tai Chi Easy)
Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks.
Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks.
|
辅助研究
Receive Tai Chi Easy class, DVD, and exercise manual
|
|
有源比较器：Group II (educational control)
Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
|
辅助研究
Receive readings and attend book club
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in peripheral sensory neuropathy, assessed by Peripheral Neuropathy Question, European Organization for Research and Treatment of Cancer (EORTC)-30, EORTC-Chemotherapy-induced peripheral neuropathy-20, and the modified Total Neuropathy Score
大体时间：Baseline up to 2 months
|
Will be assessed with a simple t-test of mTNS means.
Additional analyses of factors assessed will similarly be conducted (and overall analysis of variance when combining outcome variable assessment at the three time points, and models of factor contribution with logistic regression if appropriate).
|
Baseline up to 2 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
|
|
Changes in body mass index assessed by weight and height
大体时间：Baseline up to 2 months
|
Will be measured directly using standardized protocols with medical-quality calibrated balance scales.
|
Baseline up to 2 months
|
|
Changes in cognitive performance assessed by digit span and letter-number sequencing
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
|
|
Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
|
|
Changes in fatigue assessed by Fatigue Symptom Inventory
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
|
|
Changes in pain assessed by Medical Outcomes Study-Short Form 36
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
|
|
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
大体时间：Baseline up to 2 months
|
Baseline up to 2 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年8月1日
初级完成 (实际的)
2017年1月18日
研究完成 (实际的)
2017年1月18日
研究注册日期
首次提交
2013年7月12日
首先提交符合 QC 标准的
2013年11月4日
首次发布 (估计)
2013年11月11日
研究记录更新
最后更新发布 (实际的)
2018年3月12日
上次提交的符合 QC 标准的更新
2018年3月8日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.