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

Alona Courtney, Rachel O'Connell, Tim Rattay, Baek Kim, Ramsey I Cutress, Cliona C Kirwan, Ashu Gandhi, Patricia Fairbrother, Nisha Sharma, Christopher W J Cartlidge, Kieran Horgan, Stuart A McIntosh, Daniel R Leff, Raghavan Vidya, Shelley Potter, Chris Holcombe, Ellen Copson, Charlotte E Coles, Rajiv V Dave, Alona Courtney, Rachel O'Connell, Tim Rattay, Baek Kim, Ramsey I Cutress, Cliona C Kirwan, Ashu Gandhi, Patricia Fairbrother, Nisha Sharma, Christopher W J Cartlidge, Kieran Horgan, Stuart A McIntosh, Daniel R Leff, Raghavan Vidya, Shelley Potter, Chris Holcombe, Ellen Copson, Charlotte E Coles, Rajiv V Dave

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.

Keywords: Audit; Breast cancer; COVID-19; Outcomes; Standard treatment; Treatment.

© 2020 Published by Elsevier Ltd on behalf of Surgical Associates Ltd.

Figures

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Fig. 1
Phases of data collection.

References

    1. Cancer Research UK, Breast cancer statistics, 2020. (Accessed 30 May 2020.
    1. Lillie P.J., Samson A., Li A., Adams K., Capstick R., Barlow G.D., Easom N., Hamilton E., Moss P.J., Evans A., Ivan M., Phe Incident T., Taha Y., Duncan C.J.A., Schmid M.L.N. The Airborne Hcid, Novel coronavirus disease (Covid-19): the first two patients in the UK with person to person transmission. J. Infect. 2020;80(5):578–606.
    1. Mahase E. Covid-19: UK records first death, as world's cases exceed 100 000. BMJ. 2020;368
    1. BBC, Coronavirus: Woman in 70s becomes first virus fatality in UK, 5 March 2020. . (Accessed 15 June 2020.
    1. World Health Organization, WHO Coronavirus Disease (COVID-19) Dashboard, 2020. . (Accessed 26 May 2020).
    1. Association of Breast Surgery, Statement from the association of breast surgery, 15th march 2020. Confidential advice for health professionals, 2020. . (Accessed 26 May 2020).
    1. C. Coles, Guidelines on radiation therapy for breast cancer during the COVID-19 pandemic, 2020. . (Accessed 26 May 2020.
    1. Coles C.E., Aristei C., Bliss J., Boersma L., Brunt A.M., Chatterjee S., Hanna G., Jagsi R., Kaidar Person O., Kirby A., Mjaaland I., Meattini I., Luis A.M., Marta G.N., Offersen B., Poortmans P., Rivera S. International guidelines on radiation therapy for breast cancer during the COVID-19 pandemic. Clin. Oncol. (R. Coll. Radiol.) 2020;32(5):279–281.
    1. Murray Brunt A., Haviland J.S., Wheatley D.A., Sydenham M.A., Alhasso A., Bloomfield D.J., Chan C., Churn M., Cleator S., Coles C.E., Goodman A., Harnett A., Hopwood P., Kirby A.M., Kirwan C.C., Morris C., Nabi Z., Sawyer E., Somaiah N., Stones L., Syndikus I., Bliss J.M., Yarnold J.R., Alhasso A., Armstrong A., Bliss J., Bloomfield D., Bowen J., Brunt M., Chan C., Chantler H., Churn M., Cleator S., Coles C., Donovan E., Goodman A., Griffin S., Haviland J., Hopwood P., Kirby A., Kirk J., Kirwan C., MacLennan M., Morris C., Nabi Z., Sawyer E., Sculphur M., Sinclair J., Somaiah N., Stones L., Sydenham M., Syndikus I., Tremlett J., Venables K., Wheatley D., Yarnold J. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020;395(10237):1613–1626.
    1. M. Brunt, S. Chakraborty, S. Chatterjee, S. Cleator, C. Coles, A. Kirby, D. Leff, N. Somaiah, J. Yarnold, Emergency guidelines for pre-operative breast radiotherapy during the COVID- 19 pandemic., 2020. . (Accessed 26 May 2020).
    1. National Institute for Health and Care Excellence, COVID-19 rapid guideline: delivery of systemic anticancer treatments. NICE guideline [NG161], 27 April 2020. . (Accessed 15 June 2020).
    1. van de Haar J., Hoes L.R., Coles C.E., Seamon K., Frohling S., Jager D., Valenza F., de Braud F., De Petris L., Bergh J., Ernberg I., Besse B., Barlesi F., Garralda E., Piris-Gimenez A., Baumann M., Apolone G., Soria J.C., Tabernero J., Caldas C., Voest E.E. Caring for patients with cancer in the COVID-19 era. Nat. Med. 2020;26(5):665–671.
    1. Pardo R., Algara M., Montero-Fernández M.A., Sanz X., Vernet M., Rodríguez N., Andrés-Luna R., Piñero A., Ciérvide R., Córdoba R., Dave R.V., Montero Á., Osorio I., Argudo N., Salido S., Bernar J., Pritchard S., Alves N.F., Nicolau P., Orihuela P., Jiménez M. Diagnosis and locoregional treatment of patients with breast cancer during the COVID-19 pandemic. Revista de Senología y Patología Mamaria. 2020
    1. CovidSurg C., Nepogodiev D., Bhangu A. Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans. Br. J. Surg. 2020
    1. Lee L.Y.W., Cazier J.B., Starkey T., Turnbull C.D., U.K.C.C.M.P. Team, Kerr R., Middleton G. COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study. Lancet. 2020
    1. Vuagnat P., Frelaut M., Ramtohul T., Basse C., Diakite S., Noret A., Bellesoeur A., Servois V., Hequet D., Laas E., Kirova Y., Cabel L., Pierga C. Institut Curie Breast J.Y., C. Group, Bozec L., Paoletti X., Cottu P., Bidard F.C. COVID-19 in breast cancer patients: a cohort at the Institut Curie hospitals in the Paris area. Breast Cancer Res. 2020;22(1):55.
    1. Tasoulis M.K., Roche N., MacNeill F. Rationalizing breast cancer surgery during the COVID-19 pandemic. Eur. J. Surg. Oncol. 2020
    1. A. Lee, P. Carder, D. Deb, M. Howe, F. Knox, J. Shrimankar, N. Anderson, J. Cooke, I. Ellis, J. Jenkins, T. Stephenson, R. Wilson, Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening., June 2016. . (Accessed 30 May 2020).
    1. W.M.R.C. CholeS Study Group Population-based cohort study of outcomes following cholecystectomy for benign gallbladder diseases. Br. J. Surg. 2016;103(12):1704–1715.
    1. Jamjoom A.A., Phan P.N., Hutchinson P.J., Kolias A.G. Surgical trainee research collaboratives in the UK: an observational study of research activity and publication productivity. BMJ Open. 2016;6(2)
    1. Baker E., Kim B., Rattay T., Williams K., Ives C., Remoundos D., Holcombe C., Gardiner M.D., Jain A., Sutton R., Achuthan R., Turton P., Fairbrother P., Brock L., Aggarwal S., Basu N., Murphy J., Trickey A., Macmillan R.D., Potter S., Tea M.S.G., Mammary Fold A., C. Research The TeaM (Therapeutic Mammaplasty) study: protocol for a prospective multi-centre cohort study to evaluate the practice and outcomes of therapeutic mammaplasty. Int. J. Surg. Protoc. 2016;1:3–10.
    1. Dave R., O'Connell R., Rattay T., Tolkien Z., Barnes N., Skillman J., Williamson P., Conroy E., Gardiner M., Harnett A., O'Brien C., Blazeby J., Potter S., Holcombe C., C. Breast Reconstruction Research The iBRA-2 (immediate breast reconstruction and adjuvant therapy audit) study: protocol for a prospective national multicentre cohort study to evaluate the impact of immediate breast reconstruction on the delivery of adjuvant therapy. BMJ Open. 2016;6(10)
    1. Irwin G.W., Bannon F., Coles C.E., Copson E., Cutress R.I., Dave R.V., Grayson M., Holcombe C., Irshad S., O'Brien C., O'Connell R.L., Palmieri C., Shaaban A.M., Sharma N., Singh J., Whitehead I., Potter S., McIntosh S.A. The NeST (neoadjuvant systemic therapy in breast cancer) study - Protocol for a prospective multi-centre cohort study to assess the current utilization and short-term outcomes of neoadjuvant systemic therapies in breast cancer. Int. J. Surg. Protoc. 2019;18:5–11.
    1. Potter S., Conroy E.J., Cutress R.I., Williamson P.R., Whisker L., Thrush S., Skillman J., Barnes N.L.P., Mylvaganam S., Teasdale E., Jain A., Gardiner M.D., Blazeby J.M., Holcombe C., B.R.A.S.G. i, C. Breast Reconstruction Research Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study. Lancet Oncol. 2019;20(2):254–266.
    1. Harris P.A., Taylor R., Thielke R., Payne J., Gonzalez N., Conde J.G. Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support. J. Biomed. Inform. 2009;42(2):377–381.
    1. Harris P.A., Taylor R., Minor B.L., Elliott V., Fernandez M., O'Neal L., McLeod L., Delacqua G., Delacqua F., Kirby J., Duda S.N., R.E. Consortium The REDCap consortium: building an international community of software platform partners. J. Biomed. Inform. 2019;95
    1. REDCap, Citations, 2020. . (Accessed 26 May 2020).
    1. von Elm E., Altman D.G., Egger M., Pocock S.J., Gotzsche P.C., Vandenbroucke J.P., Initiative S. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806–808.
    1. National Institute for Health and Care Excellence (NICE), Early and locally advanced breast cancer: diagnosis and management (NICE Guideline NG101), 2018. . (Accessed 3 June 2020).
    1. Vidya R., Rubio I., Resende P., Rancati A., Kolacinska-Voytkuv A., Salgarello M., Becker H. Should breast reconstruction and breast oncoplastic procedures be performed during the coronavirus pandemic? ecancer. 2020;14:1041.
    1. The Royal College of Surgeons of England, Association of Breast Surgery, British Association of Plastic Reconstructive and Aesthetic Surgeons, Royal College of Nursing, The NHS Information Centre for health and social care, National Mastectomy and Breast Reconstruction Audit. A national audit of provision and outcomes of mastectomy and breast reconstruction surgery for women in England Second Annual Report 2009, 2009. . (Accessed 15 June 2020).
    1. Al-Ghazal S.K., Fallowfield L., Blamey R.W. Comparison of psychological aspects and patient satisfaction following breast conserving surgery, simple mastectomy and breast reconstruction. Eur. J. Cancer. 2000;36(15):1938–1943.
    1. Fernández-Delgado J., López-Pedraza M.J., Blasco J.A., Andradas-Aragones E., Sánchez-Méndez J.I., Sordo-Miralles G., Reza M.M. Satisfaction with and psychological impact of immediate and deferred breast reconstruction. Ann. Oncol. 2008;19(8):1430–1434.
    1. Smith I.E., Dowsett M., Ebbs S.R., Dixon J.M., Skene A., Blohmer J.U., Ashley S.E., Francis S., Boeddinghaus I., Walsh G. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial. J. Clin. Oncol. 2005;23(22):5108–5116.
    1. Cataliotti L., Buzdar A.U., Noguchi S., Bines J., Takatsuka Y., Petrakova K., Dube P., de Oliveira C.T. Comparison of anastrozole versus tamoxifen as preoperative therapy in postmenopausal women with hormone receptor-positive breast cancer: the Pre-Operative “Arimidex” Compared to Tamoxifen (PROACT) trial. Cancer. 2006;106(10):2095–2103.
    1. Toi M., Saji S., Masuda N., Kuroi K., Sato N., Takei H., Yamamoto Y., Ohno S., Yamashita H., Hisamatsu K., Aogi K., Iwata H., Takada M., Ueno T., Chanplakorn N., Suzuki T., Sasano H. Ki67 index changes, pathological response and clinical benefits in primary breast cancer patients treated with 24 weeks of aromatase inhibition. Cancer Sci. 2011;102(4):858–865.

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