Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
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
- 否
入选标准
- •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
排除标准
- •Recurrence of cancer or other active cancer
- •Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
- •Uncontrolled diabetes, untreated hypothyroidism
研究组 & 干预措施
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Exercise Intervention (Behavioral)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Educational Intervention (Other)
结局指标
主要结局
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
时间窗: 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).
次要结局
- Changes in body mass index assessed by weight and height(Baseline up to 2 months)
- Changes in cognitive performance assessed by digit span and letter-number sequencing(Baseline up to 2 months)
- Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)(Baseline up to 2 months)
- Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)(Baseline up to 2 months)
- Changes in fatigue assessed by Fatigue Symptom Inventory(Baseline up to 2 months)
- Changes in pain assessed by Medical Outcomes Study-Short Form 36(Baseline up to 2 months)
- Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph(Baseline up to 2 months)