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

What is it about?

Available studies that focused on patient-reported outcomes (PROs) were mainly from one institution or of small sample size. The variations across hospitals and regions were not fully analyzed. A multicenter prospective patient report outcome-reconstruction and oncoplastic cohort (PRO-ROC) will be planned to assess the PROs for Chinese breast cancer patients who will undergo breast reconstruction (BR) or oncoplastic breast-conserving surgery (OBCS). The inclusion criteria are female breast cancer patients >18 years old, who will undergo BR or OBCS. This cohort will include at least 10000 patients (about 5000 patients who undergo BR, and 5000 patients who undergo OBCS). The exposures were the surgery types: BR and OBCS regardless of the techniques and materials they used. The primary endpoint will be PROs, which include BREAST-Q, quality of life (EORTC QLQ-C30), EORTC QLQ-BR23). All patients will be followed up to 24 months after operations. All data will be collected using an app software. Data will be analysed using SPSS and stata software. This cohort study will be the largest cohort focusing on PROs about BR and OBCS in China. This large cohort will provide us the PROs after BR and OBCS in China, and find the factors that affect patients’ satisfactions. This study will also provide the assessment of the complications for BR and OBCS in China, and explore the variables that might affect the occurrence of complications. This study will develop the standards for the indictors, risk, prognosis of BR and OBCS, and provide suggestion for future clinical practice and researches.

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