The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. The study aims to establish a long-term clinical enrollment criteria and process for TCM adjuvant therapy in breast cancer. The research design will utilize a prospective cohort study and real-world cross-sectional observational research method to obtain clinical data and survival status of the patients.
Two-group parallel experimental design. One group received conventional Western medicine treatment, while the other group received combined treatment with both traditional Chinese and Western medicine treatment. A. Patients who opt for integrated traditional Chinese medicine (TCM) treatment will be referred to the TCM outpatient department, where a TCM practitioner will prescribe TCM prescriptions, followed by the initial clinical effectiveness assessment. B. Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments. C. Both the Western medicine treatments and TCM treatments received by the patients are covered by health insurance, and patients do not need to pay anyadditional fees. D. Both the "Conventional Western Medicine Treatment Group" and the "Integrated Western and Chinese Medicine Treatment Group" will undergo another clinical effectiveness assessment (blood tests) before the next cancer treatment. E. A questionnaire will be administered before starting chemotherapy and before each research visit for treatment evaluation. A final evaluation will be conducted within four weeks after the last radiation or chemotherapy session. The questionnaire includes the EOG, BFI-T, FACT-B,EORTC-QLQ-C30, EORTC-QLQ-BR23, WHOQOL-BREF, and BCQ.
Study Type
OBSERVATIONAL
Enrollment
200
Participants in the standard care group receive conventional chemotherapy for breast cancer according to clinical guidelines. Treatment includes 8 cycles of chemotherapy administered every 3 weeks. No Traditional Chinese Medicine (TCM) is provided in this group.
Participants in the integrative care group receive conventional chemotherapy combined with Traditional Chinese Medicine (TCM) treatment. Herbal formulas are prescribed by licensed TCM physicians based on syndrome differentiation and are aimed at strengthening vital qi and harmonizing stomach function. Treatment is conducted under Taiwan's National Health Insurance coverage.
Buddhist Taipei Tzu Chi General Hospital
New Taipei City, Taiwan
RECRUITINGFACT-B (Functional Assessment of Cancer Therapy - Breast)
The FACT-B is a validated questionnaire used to assess quality of life in breast cancer patients. It includes domains such as physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns.
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
The EORTC QLQ-C30 is a validated, cancer-specific, patient-reported quality of life questionnaire. It consists of 30 items covering five functional domains (physical, role, emotional, cognitive, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and several single items (e.g., dyspnea, insomnia). It is widely used in cancer clinical trials for measuring changes in quality of life during treatment.
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
The WHOQOL-BREF is a 26-item questionnaire developed by the World Health Organization to assess an individual's perception of their quality of life in four domains: physical health, psychological health, social relationships, and environment. It is widely used for evaluating general quality of life in clinical populations.
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
BCQ (Body Constitution Questionnaire)
The BCQ is a self-reported questionnaire developed based on Traditional Chinese Medicine (TCM) theory. It evaluates individual body constitution types, including Yang deficiency, Yin deficiency, and Stasis constitution. The tool is useful in assessing patients' constitutional status and monitoring changes during treatment, especially in integrative TCM studies.
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
EQ-5D (EuroQol Five Dimensions Questionnaire)
The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analog scale (VAS) to rate overall health. It is widely used in health economic evaluations and patient-reported outcome assessments.
Time frame: On the day of each chemotherapy cycle (Day 1 of each cycle)
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