【ChiCTR1900021215】The effectiveness of dancing program on relieving the symptom cluster of fatigue-sleep disturbance-depression among breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial

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基本信息

登记号

ChiCTR1900021215

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-02-01

临床申请受理号

靶点

适应症

乳腺癌

试验通俗题目

The effectiveness of dancing program on relieving the symptom cluster of fatigue-sleep disturbance-depression among breast cancer patients undergoing adjuvant chemotherapy: A randomized controlled trial

试验专业题目

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

999077

联系人通讯地址

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临床试验信息

试验目的

The aim of the study is to examine the effectiveness of a 16-week dancing program on the symptom cluster of fatigue-sleep disturbance-depression and quality of life in Chinese breast cancer patients undergoing adjuvant chemotherapy.

试验分类

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试验类型

半随机对照

试验分期

Ⅰ期

随机化

non-involved personnel will perform the randomization and concealed allocation using computer-generated random allocation list and opaque envelopes.

盲法

未说明

试验项目经费来源

No funding

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-02-01

试验终止时间

2019-12-31

是否属于一致性

入选标准

1) aged 18 years or older; 2) newly diagnosed with stage I-III breast cancer; 3) undergone surgery for breast cancer and scheduled to receive a minimum six cycles of adjuvant chemotherapy; 4) not participating in any other extra moderate intensity physical exercise program such as walking or Yoga that reaches a certain dosage of 150 minutes per week; 5) literate and able to communicate with Chinese; 6) having a smartphone, which can access to the Internet for receiving intervention materials and messages.；

排除标准

1) recurrent patients; 2) diagnosed with other types of cancer; 3) having contraindication to exercise training, including unstable cardiac diseases (i.e. coronary artery disease with current exacerbation within one month, unstable angina, uncontrolled arrhythmia, symptomatic heart failure, symptomatic severe aortic stenosis, acute pulmonary embolus or pulmonary infarction, acute myocarditis or pericarditis, intracardiac thrombus, acute systematic infection, and third degree heart block), severe arterial hypertension (i.e. systolic blood pressure of > 200 mm Hg and/or a diastolic blood pressure of > 110 mm Hg) at rest, uncontrolled metabolic disease, and musculoskeletal or rheumatoid disorders that are exacerbated by exercise, according to the ACSM (American College of, Sports Medicine, 2018); 4) having a history of psychiatric diseases.；

研究者信息

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试验机构

no sponsor

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

999077

联系人通讯地址