Prostate cancer is the most common malignant tumor of the urinary system that seriously threatens the life and health of men, with a high incidence worldwide, especially in Europe, America, Australia and New Zealand. The incidence of prostate cancer in China and other country of Asia is lower than that in Europe and the United States. But the incidence of prostate cancer is increasing year by year in China, with the aging of population and the continuous development of social economy. The treatment of prostate cancer mainly includes surgery, androgen deprivation therapy, radiotherapy, chemotherapy and new endocrine drugs. However, 80% of prostate cancer patients also had received Traditional Chinese Medicine (TCM) treatment in China, especially during the watchful waiting stage, androgen deprivation therapy stage, and the advanced stage of metastatic castration-resistant prostate cancer, TCM treatment even plays a major role. Nevertheless, the outcomes of clinical trials are clearly inconsistent, which reduce the value of clinical trials. Meanwhile, we searched the COMET website and found 15 core indicator set studies on prostate cancer and 63 core indicator set studies on TCM, but there is no standardized set of outcomes for prostate cancer in clinical trials of TCM. This research aims to establish a COS for clinical trials of prostate cancer in TCM.
ContributorsYingjie Jia (the principal investigator)1, Xiaojiang Li (the principal investigator)1, Yao Zhang 1, Shanqi Guo 1, Binxu Sun 1, Ruiyu Mou 1, Chang Su 1, Honggen Liu 1, Liang Wang 2, Jianqiang Zhu 3, Chaoran wang 4, Xiaodi Liu 4, Ruijin Qiu 5, Hongcai Shang 5, Jianfei Su 4, Yang Liao 4, Huichuan Tian 4
1. The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
2. Tianjin Medical University General Hospital.
3. Tianjin Medical University Second Hospital.
4. Tianjin University of Traditional Chinese Medicine, Tianjin, China.
5. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Disease Category: Cancer
Disease Name: Prostate cancer
Age Range: 18 - 90
Sex: Male
Nature of Intervention: Traditional Chinese Medicine
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Epidemiologists
- Ethicists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
1. Firstly, through literature review, retrospective case study and cross-sectional investigation, the different syndromal conditions of prostate cancer treated by TCM will be determined, and the names and factors of syndromal conditions will be extracted.
2. Construct the list of outcome indicators for TCM treatment of prostate cancer and standardize the name of outcome indicators.
3. In-depth interviews (especially for patients) will be held to improve the list of relevant outcome indicators.
4. Through two rounds of Delphi surveys, the views of different stakeholder groups on the importance of outcome indicators will be obtained and the core indicator set will be determined.
5. Report research results, define measurement tools and measurement time of core indicators.