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      Chinese multicentre prospective registry of breast cancer patient-reported outcome-reconstruction and oncoplastic cohort (PRO-ROC): a study protocol

      protocol

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          Abstract

          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.

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          Most cited references39

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          The BREAST-Q in surgical research: A review of the literature 2009-2015.

          Wess A Cohen, Lily Mundy, Tiffany Ballard … (2016)
          Health outcomes research has gained considerable traction over the past decade as the medical community attempts to move beyond traditional outcome measures such as morbidity and mortality. Since its inception in 2009, the BREAST-Q has provided meaningful and reliable information regarding health-related quality of life (HRQOL) and patient satisfaction for use in both clinical practice and research. In this study, we review how researchers have used the BREAST-Q and how it has enhanced our understanding and practice of plastic and reconstructive breast surgery.
          Article 0 comments Cited 103 times – based on 0 reviews     Review now
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            Radiotherapy in the setting of breast reconstruction: types, techniques, and timing.

            Babak Mehrara, Alice Ho, Zishuo Hu … (2017)
            As the use of breast reconstruction and postmastectomy radiotherapy (PMRT) has increased over the past decade, the typical approach to integrating radiotherapy with breast reconstruction has provoked intense controversy in the management of breast cancer. PMRT can lead to an increased frequency of complications in the reconstructed breast. Conversely, the reconstructed breast can increase the complexity of radiotherapy delivery. How to minimise the frequency of complications without compromising oncological or cosmetic outcomes of the reconstructed breast is an important shared multidisciplinary goal for oncologists and their patients. Several questions remain, however, regarding the type of reconstruction that should be used with PMRT, when reconstruction should be done relative to PMRT and whether radiotherapy treatment should be directed towards the tissue expander or the implant for women who opt for a two-stage expander-implant reconstruction. Following advances in the planning of radiotherapy treatment, new questions about the application of these technologies in the setting of breast reconstruction have arisen. In this Review, we address these questions by reviewing contemporary evidence on the optimal integration of radiotherapy and breast reconstruction in the management of breast cancer.
            Article 0 comments Cited 60 times – based on 0 reviews     Review now
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              Patient-reported outcome measures (PROMs) in the management of lung cancer: A systematic review.

              Youssef Ben Bouazza, Ibrahim Chiairi, Ouiam El Kharbouchi … (2017)
              Lung cancer is often associated with a poor quality of life, as reflected by patient-reported outcome measures (PROMs). The aim of this paper is to describe and compare the PROMs that are available. In this manuscript, we review the impact of PROMs on the management of lung cancer. Quality of the study and risk of bias were assessed using the appraisal tools recommended by the Dutch Cochrane Center. Out of 51 studies included in this review, ten instruments were identified and categorized as either generic, cancer- or lung cancer-specific. PROMs are primarily applied in scientific research to compare the therapy outcomes and in drug development to support labeling claims. The interest for the routine use of PROMs in daily practice is growing, which has positive effects on the communication with the patient, mutual decision making and the monitoring and managing of the patient. Besides that, PROMs have an independent prognostic value for survival in lung cancer and economic evaluations can be conducted using their results. Electronic platforms simplify the implementation of PROMs in the daily clinic. The EORTC QLQ-C30 and its lung cancer-specific module QLQ-LC13 are the most frequently used instruments in lung cancer patients. PROMs have the potential to improve the quality of care with a proper implementation in the routine practice. PROMS are needed to value and understand the experience of the patient.
              Article 0 comments Cited 47 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2019
                Publication date (Electronic): 15 December 2019
                Volume: 9
                Issue: 12
                Electronic Location Identifier: e032945
                Affiliations
                [1 ] departmentDepartment of Breast Surgery , Shanghai Cancer Hospital, Fudan University , Shanghai, China
                [2 ] departmentDepartment of Oncology , Shanghai Medical College, Fudan University , Shanghai, China
                [3 ] departmentDepartment of Endocrine and Breast Surgery , The First Affiliated Hospital of Chongqing Medical University , Chongqing, Sichuan, China
                [4 ] departmentDepartment of Breast Oncoplastic Surgery , Tianjin Medical University Cancer Institute and Hospital , Tianjin, Tianjin, China
                [5 ] departmentDepartment of Breast Surgery , The First Affiliated Hospital of China Medical University , Shenyang, Liaoning, China
                [6 ] departmentDepartment of Breast Cancer , Guangdong Provincial People’s Hospital , Guangzhou, Guangdong, China
                [7 ] departmentDepartment of Plastic Surgery , Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital , Nanjing, Jiangsu, China
                [8 ] departmentDepartment of Thyroid, Breast and Vascular Surgery , Xijing Hospital, Air Force Medical University , Xian, China
                [9 ] departmentDepartment of Oncology, Plastic Surgery , Hunan Province Cancer Hospital , Changsha, China
                [10 ] departmentDepartment of Breast Surgery , Hunan Province Cancer Hospital , Changsha, China
                [11 ] departmentDepartment of Breast Surgical Oncology , National Cancer Center , Beijing, China
                [12 ] departmentDepartment of Breast Surgical Oncology , National Clinical Research Center for Cancer , Beijing, China
                [13 ] departmentDepartment of Breast Surgical Oncology , Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing, China
                [14 ] departmentDepartment of Breast Surgery , The First Affiliated Hospital, Zhejiang University, School of Medicine , Hangzhou, Zhejiang, China
                [15 ] departmentDepartment of Breast Surgery , The First Affiliated Hospital of Xiamen University , Xiamen, Fujian, China
                [16 ] departmentDepartment of Breast and Head & Neck , Affiliated Cancer Hospital of Xinjiang Medical University , Urumqi, China
                [17 ] departmentBreast Cancer Center , Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science & Technology , Wuhan, Hubei, China
                [18 ] departmentBreast Disease Center , The Affiliated Hospital of Qingdao University , Qingdao, Shandong, China
                [19 ] departmentDepartment of Breast Surgery , Affiliated Hangzhou First People’s Hospital, Zhejiang University, School of Medicine , Hangzhou, Zhejiang, China
                [20 ] Collaborative Innovation Center for Cancer Medicine , Shanghai, China
                Author notes
                [Correspondence to ] Professor Jiong Wu; wujiong1122@ 123456vip.sina.com
                Author information
                http://orcid.org/0000-0002-8103-0505
                Article
                Publisher ID: bmjopen-2019-032945
                DOI: 10.1136/bmjopen-2019-032945
                PMC ID: 6924782
                PubMed ID: 31843846
                SO-VID: 65467cd5-549f-457f-bc77-b0328932e85b
                Copyright © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 22 July 2019
                Date revision received : 29 October 2019
                Date accepted : 07 November 2019
                Categories
                Subject: Surgery
                Subject: Protocol
                Subject: 1506
                Subject: 1737
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: patient reported outcome measures,breast reconstruction,oncoplastic breast-conserving surgery,cohort,study protocol,breast tumours
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: patient reported outcome measures, breast reconstruction, oncoplastic breast-conserving surgery, cohort, study protocol, breast tumours

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