TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

Trial Title: TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

NCT ID: NCT06337214

Condition: Breast Cancer
Neoplasm, Breast
Patient Participation
Mental Health Issue

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Reinforcing Vital Energy
Patients Association
Patients Educatioin

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy
Description: 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.
Arm group label: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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).

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Taipei City Hospital

Address:
City: Taipei
Zip: 10845
Country: Taiwan

Status: Recruiting

Contact:
Last name: Yu-Hsuan Tai, MD

Phone: +886918130891
Email: daidayangisele@gmail.com,dbb02@tpech.gov.tw

Start date: March 13, 2024

Completion date: February 28, 2025

Lead sponsor:
Agency: Taipei City Hospital
Agency class: Other

Source: Taipei City Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06337214