ChiCTR1900021215尚未招募1 期
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
No funding2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2019年2月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- fatigue
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 半随机对照
- 盲法
- 未说明
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- Female
入选标准
- •aged 18 years or older;
- •newly diagnosed with stage I-III breast cancer;
- •undergone surgery for breast cancer and scheduled to receive a minimum six cycles of adjuvant chemotherapy;
- •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;
- •literate and able to communicate with Chinese;
- •having a smartphone, which can access to the Internet for receiving intervention materials and messages.
排除标准
- •recurrent patients;
- •diagnosed with other types of cancer;
- •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);
- •having a history of psychiatric diseases.
研究组 & 干预措施
Group 1
dancing program
Group 2
usual care
结局指标
主要结局
fatigue
时间窗: before intervention (T0), at week-8 (T1), at week-16 (T2)
sleep disturbance
时间窗: before intervention (T0), at week-8 (T1), at week-16 (T2)
depression
时间窗: before intervention (T0), at week-8 (T1), at week-16 (T2)
次要结局
- cancer-related symptoms(before intervention (T0), at week-8 (T1), at week-16 (T2))
- quality of life(before intervention (T0), at week-8 (T1), at week-16 (T2))
研究者
研究点 (2)
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