The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol

Abstract

Introduction Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient’s breast cancer management will be determined. Methods and analysis This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th March 2020, are eligible for inclusion. Ethics and dissemination As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting. Registration details Each participating centre received local governance audit registration.

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

“…A multicentre national cohort study was conducted in which consecutive patients with a diagnosis or early breast cancer undergoing MDT-guided treatment recommendations during the peak of the COVID-19 pandemic were eligible for inclusion. 18 Full study information is available on bmapc.org. Patients were identified prospectively by the local participating clinical teams during the UK's 'Alert Level 4' phase of the COVID-19 pandemic (defined as 16th March (the commencement of social distancing recommendations in the United Kingdom) to 8th May [relaxation of the 'stay at home' message]).…”

“…Ethics approval was not required according to the NHS Health Research Authority online decision tool (www.hra-decisiontools.org.uk/research/). 18 We collected patient demographic data, cancer-specific data and multidisciplinary treatment recommendations in the preoperative, operative and post-operative setting. Patients on NACT prior to the pandemic could enter the study period at the peri-or post-operative multidisciplinary team meeting (MDT-M) (Fig.…”

“…An example would be if a unit's standard practice is to perform axillary node clearance after positive sentinel node, but during the alert level 4 period, a patient was recommended no further axillary surgery after positive sentinel node. 18 Hence, any alterations in management identified were as a direct result of the COVID-19 pandemic, representing treatment out of the ordinary for that collaborating unit. This allowed us to reflect the changes caused by the pandemic, whilst taking into account the background variability of practice across the United Kingdom.…”

“…In particular, the 'phased' data collection offered by the study design allowed us to perform validation checks to ensure consistency of data entry (Supplementary Table 3). Specifically, we calculated the percentage of concordance as the agreement of phases 1 and 2 of the study 18 divided by total cases, for each category of 'COVID-altered' management.…”

“…In patients commenced on preoperative/'bridging' ET, 210 patients went on to have surgery by the end of the study. The median length of time of ET for these patients was 22 days (IQR [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. The most common reason for proceeding with surgery early was unexpected availability of theatre capacity (53%).…”