A Holistic Medical Approach - The Effect of "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on Breast Cancer Patients Undergoing Cancer Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Questionnaire: Constitution in Chinese Medicine Questionnaire
研究概览
简要总结
The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:
Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?
Participants will:
Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.
Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.
This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer.
详细描述
This study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" combined with the use of the herbal formulation at Taipei City Hospital, can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery.
This study adopts a holistic healthcare approach, integrating the Traditional Chinese Medicine (TCM) formulation Kuan-Sin-Yin from Taipei City Hospital with the "TCM Therapy Program for Reinforcing Vital Energy" course offered by a cancer patient support organization, to research its effects on breast cancer patients undergoing conventional medical treatment. International standard questionnaires and other inquiries are utilized to evaluate the impact on patients' physical, emotional, spiritual, and social well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 years and above and below 85 years, willing to voluntarily participate in the study.
- •Diagnosed with malignant breast tumors, ICD-10: C50, by conventional medicine.
- •Patients currently undergoing cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.
排除标准
- •Diagnosed solely with carcinoma in situ or benign tumors, including fibrocystic breast conditions, by conventional medicine.
- •Patients regularly receiving Astragalus polysaccharide injections.
- •Patients with a history of allergies to Traditional Chinese Medicine.
- •Pregnant or breastfeeding women.
- •Individuals with a drug addiction habit, including both narcotic and non-narcotic drugs.
- •Any other situation where the participant is unable to cooperate (e.g., due to any factor that prevents participation, deemed unsuitable for participation by study staff, unwillingness to sign the consent form).
结局指标
主要结局
Questionnaire: Constitution in Chinese Medicine Questionnaire
时间窗: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment
Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)
时间窗: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being
Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)
时间窗: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis for measuring the quality of life in patients with breast cancer
次要结局
- Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"(Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks)
研究者
Chung-Hua Hsu
Attending physician of the hospital
Taipei City Hospital