Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol
Introduction Available patient-reported outcome (PRO) studies are mainly from single institution or of small sample size, and the variations across hospitals and regions were not fully analysed. A multicentre, prospective, patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC) will...
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e032945.full |
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| author | Haibo Wang Xiang Wang Jian Liu Jian Yin Lun Li Benlong Yang Hongyuan Li Feng Jin Siyuan Han Ning Liao Jingping Shi Rui Ling Zan Li Lizhi Ouyang Peifen Fu Zhong Ouyang Binlin Ma Xinhong Wu Zhimin Shao Jiong Wu |
| author_facet | Haibo Wang Xiang Wang Jian Liu Jian Yin Lun Li Benlong Yang Hongyuan Li Feng Jin Siyuan Han Ning Liao Jingping Shi Rui Ling Zan Li Lizhi Ouyang Peifen Fu Zhong Ouyang Binlin Ma Xinhong Wu Zhimin Shao Jiong Wu |
| author_sort | Haibo Wang |
| collection | DOAJ |
| description | Introduction Available patient-reported outcome (PRO) studies are mainly from single institution or of small sample size, and the variations across hospitals and regions were not fully analysed. A multicentre, prospective, patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs of Chinese patients with breast cancer who will undergo breast reconstruction (BR) or oncoplastic breast-conserving surgery (OBCS).Methods and analysis The inclusion criteria are female patients with breast cancer aged >18 years old who will undergo BR or OBCS. This cohort will include at least 10 000 consecutive patients (about 5000 patients who will undergo BR and 5000 patients who will undergo OBCS). The exposures were surgery types: BR and OBCS regardless of the techniques and materials used. The primary endpoint will be PROs, which include BREAST-Q and quality of life (European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and EORTC QoL Breast Cancer-specific version (QLQ-BR23)). All patients will be followed up to 24 months after operations. All data will be prospectively collected using an app software. Data will be analysed using SPSS and Stata software.Ethics and dissemination This study follows the Helsinki Declaration. All patients will be asked to sign an informed consent before enrolment. The results of this study will be presented at national and international meetings and published in a scientific peer-reviewed journal.Trial registration number NCT04030845; Pre-results. |
| format | Article |
| id | doaj-art-a331955aaa7a47a8a819ef0590a07605 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-a331955aaa7a47a8a819ef0590a076052025-08-20T02:51:18ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2019-032945Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocolHaibo Wang0Xiang Wang1Jian Liu2Jian Yin3Lun Li4Benlong Yang5Hongyuan Li6Feng Jin7Siyuan Han8Ning Liao9Jingping Shi10Rui Ling11Zan Li12Lizhi Ouyang13Peifen Fu14Zhong Ouyang15Binlin Ma16Xinhong Wu17Zhimin Shao18Jiong Wu19Peking University Clinical Research Institute, Peking University First Hospital, Beijing, ChinaDepartment of Clinical Psychology, the Third Xiangya Hospital, Central South University, Changsha, Hunan, China3 School of Nursing and Rehabilitation, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, ChinaSchool of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China2 Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China1 Department of Breast Surgery, Shanghai Cancer Hospital, Fudan University, Shanghai, ChinaDepartment of Emergency Medicine, The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, ChinaFrom the Department of Anesthesiology, The First Hospital of China Medical University, Shenyang, China5 Department of Breast Surgery, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China6 Department of Breast Cancer, Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China7 Department of Plastic Surgery, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, China8 Department of Thyroid, Breast and Vascular Surgery, Xijing Hospital, Air Force Medical University, Xian, China9 Department of Oncology, Plastic Surgery, Hunan Province Cancer Hospital, Changsha, China10 Department of Breast Surgery, Hunan Province Cancer Hospital, Changsha, China14 Department of Breast Surgery, The First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China15 Department of Breast Surgery, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China16 Department of Breast and Head & Neck, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, China17 Breast Cancer Center, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China1 Department of Breast Surgery, Shanghai Cancer Hospital, Fudan University, Shanghai, ChinaprofessorIntroduction Available patient-reported outcome (PRO) studies are mainly from single institution or of small sample size, and the variations across hospitals and regions were not fully analysed. A multicentre, prospective, patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs of Chinese patients with breast cancer who will undergo breast reconstruction (BR) or oncoplastic breast-conserving surgery (OBCS).Methods and analysis The inclusion criteria are female patients with breast cancer aged >18 years old who will undergo BR or OBCS. This cohort will include at least 10 000 consecutive patients (about 5000 patients who will undergo BR and 5000 patients who will undergo OBCS). The exposures were surgery types: BR and OBCS regardless of the techniques and materials used. The primary endpoint will be PROs, which include BREAST-Q and quality of life (European Organisation for Research and Treatment (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and EORTC QoL Breast Cancer-specific version (QLQ-BR23)). All patients will be followed up to 24 months after operations. All data will be prospectively collected using an app software. Data will be analysed using SPSS and Stata software.Ethics and dissemination This study follows the Helsinki Declaration. All patients will be asked to sign an informed consent before enrolment. The results of this study will be presented at national and international meetings and published in a scientific peer-reviewed journal.Trial registration number NCT04030845; Pre-results.https://bmjopen.bmj.com/content/9/12/e032945.full |
| spellingShingle | Haibo Wang Xiang Wang Jian Liu Jian Yin Lun Li Benlong Yang Hongyuan Li Feng Jin Siyuan Han Ning Liao Jingping Shi Rui Ling Zan Li Lizhi Ouyang Peifen Fu Zhong Ouyang Binlin Ma Xinhong Wu Zhimin Shao Jiong Wu Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol BMJ Open |
| title | Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol |
| title_full | Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol |
| title_fullStr | Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol |
| title_full_unstemmed | Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol |
| title_short | Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol |
| title_sort | chinese multicentre prospective registry of breast cancer patient reported outcome reconstruction and oncoplastic cohort pro roc a study protocol |
| url | https://bmjopen.bmj.com/content/9/12/e032945.full |
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