Study of Effects of Dao-yin Exercise on the Patients With Breast Cancer Post Operation and Receiving Adjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30)
研究概览
简要总结
This is a retrospective registration of a study that evaluated whether a traditional Dao-yin (mind-body exercise), called Shangshou Dao-yin, could improve sleep quality, Chinese medicine body constitution, and quality of life in breast cancer patients receiving adjuvant chemotherapy.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned to either a Dao-yin exercise group (72 participants) or a control group (78 participants) based on their preference. The exercise group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherapy, while the control group received standard care only. After withdrawals, 138 participants completed the final evaluation (66 in the Dao-yin group and 72 in the control group).
Sleep quality, body constitution (BCQ), quality of life (EORTC), and chemotherapy-related adverse effects were assessed during treatment and three weeks after chemotherapy completion. The findings may help determine whether Shangshou Dao-yin can reduce sleep disturbance and enhance well-being during cancer treatment.
详细描述
Breast cancer remains one of the most prevalent malignant diseases among women, and many patients receiving adjuvant chemotherapy experience sleep disturbance, emotional distress, fatigue, and impaired quality of life.
Shangshou Dao-yin is a traditional Dao-yin (mind-body exercise) consists of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The core principle of the Shangshou Dao-yin method is to stimulate the lower dantian, the body's source of vital energy. Dao-yin emphasizes mental focus, natural breathing, and smooth, continuous movements that follow the body's structure to harmonize internal energy flow. It requires no equipment and minimal space, making it particularly suitable for patients during chemotherapy.
This retrospective registration describes a study that evaluated whether Shangshou Dao-yin could improve sleep quality, Chinese medicine body constitution, and health-related quality of life in breast cancer patients undergoing adjuvant chemotherapy. The study was approved by the Institutional Review Board of Tri-Service General Hospital (TSGHIRB-1-105-05-045) and was conducted between January 2017 and October 2019.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned, based on preference, to either a Shangshou Dao-yin group (n = 72) or a control group (n = 78). The Dao-yin group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherap. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube) in collaboration with the Taiwan Society of Health Promotion. The control group received standard care only. After withdrawals, 138 participants (66 Dao-yin, 72 control) completed the final evaluation.
Data collection included baseline characteristics (age, sex, height, weight, marital status, education level, smoking and alcohol history, medical history, family history, pregnancy and childbirth history, food or drug allergies, and comorbidities). Cancer-related variables included TNM stage, surgical method, tumor histology, differentiation, hormone receptor status, and HER2 expression. Chemotherapy-related information included regimen, dosage, treatment cycles, dose modifications, delays, and completion of planned cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed Stage I, II, or III breast cancer with surgical tumor removal followed by adjuvant chemotherapy.
- •Age ≥ 20 years.
- •Ability to walk independently without movement restrictions.
- •Able to communicate in Mandarin or Taiwanese.
- •Provided written informed consent.
排除标准
- •Regularly practicing Tai Chi or other mind-body exercises at the time of enrollment.
- •Pre-existing chronic illnesses or symptoms that may interfere with evaluation of chemotherapy-related side effects (e.g., chronic diarrhea, neuropathy, heart failure, thromboembolic disease, chronic pulmonary or renal disease, alopecia).
- •Severe psychiatric illness (e.g., schizophrenia, major depressive disorder).
研究组 & 干预措施
Shangshou Dao-yin Group
Participants practiced Shangshou Dao-yin, a traditional mind-body exercise, for 20 minutes daily throughout the course of adjuvant chemotherapy. A standardized instructional video was provided to guide home or hospital practice.
干预措施: Shangshou Dao-yin (Behavioral)
Control Group
Participants received standard medical care during chemotherapy without any structured exercise intervention.
结局指标
主要结局
Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30)
时间窗: Baseline to 3 weeks after completion of chemotherapy
Quality of life was assessed using the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30). Scores were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
Change in Breast Cancer-Specific Quality of Life (EORTC Breast Cancer-Specific Quality of Life Questionnaire; QLQ-BR23)
时间窗: Baseline to 3 weeks after completion of chemotherapy
Breast cancer-specific quality of life was measured using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). All subscales were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
次要结局
- Change in Body Constitution (Body Constitution Questionnaire; BCQ)(Baseline to 3 weeks after completion of chemotherapy)
- Chemotherapy-related Adverse Events (CTCAE v4.0)(Baseline to 3 weeks after completion of chemotherapy)
研究者
Chien-Jung Lin
Principal Investigator and Attending Physician, Department of Traditional Chinese Medicine
Tri-Service General Hospital