TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

NCT06337214 | Recruiting DMC

• 1 other identifier: TCHIRB-11301014-E
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Neoplasm, Breast; Patient Participation; Mental Health Issue

Keywords

Breast Cancer; Reinforcing Vital Energy; Patients Association; Patients Educatioin

Outcome Measures

Primary Outcomes (3)

• Questionnaire: Constitution in Chinese Medicine Questionnaire

  Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment

  Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

• Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)

  Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being

  Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

• Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)

  Observation and analysis for measuring the quality of life in patients with breast cancer

  Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

Secondary Outcomes (1)

• 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

Study Arms (1)

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

EXPERIMENTAL

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" , 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. Evaluations will be conducted using pre- and post-tests spaced 4 to 6 weeks apart, during which participants will be administered three questionnaires.

Behavioral: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

Interventions

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy BEHAVIORAL

Comparing cancer patients who have participated in the program with those who have not, this study will examine differences in two types of quality of life questionnaires and constitution between the two groups.

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City Hospital

Taipei, 10845, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chung-Hua Hsu, MD. PhD

  Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu-Hsuan Tai, MD

CONTACT

+886918130891; daidayangisele@gmail.com, DBB02@tpech.gov.tw

Chung-Hua Hsu, MD. PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician of the hospital

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: March 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

TW (1)