Alexandra Roux, Rachel Cholerton, Jonathan Sicsic, Nora Moumjid, David P. French, Paolo Giorgi Rossi, Corinne Balleyguier, Michal Guindy, Fiona J. Gilbert, Jean-Benoit Burrion, Xavier Castells, David Ritchie, Debbie Keatley, Camille Baron, Suzette Delaloge, Sandrine de Montgolfier, Gilbert, Fiona [0000-0002-0124-9962], Apollo - University of Cambridge Repository, Apollo-University Of Cambridge Repository, Malbec, Odile, Institut de Recherche Interdisciplinaire sur les enjeux Sociaux - sciences sociales, politique, santé (IRIS), École des hautes études en sciences sociales (EHESS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Sorbonne Paris Nord, University of Manchester [Manchester], Laboratoire Interdisciplinaire de Recherche Appliquée en Economie de la Santé (LIRAES (URP_ 4470)), Université Paris Cité (UPCité), Parcours santé systémique (P2S), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Centre Léon Bérard [Lyon], Azienda Unità Sanitaria Locale di Bologna (AUSL), Institut Gustave Roussy (IGR), Imagerie thérapeutique (radiologie interventionnelle), Département d'imagerie médicale [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Ben-Gurion University of the Negev (BGU), University of Cambridge [UK] (CAM), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), IMIM-Hospital del Mar, Generalitat de Catalunya, European Cancer Leagues [Brussels, Belgium] (ECL), Independent Cancer Patients' Voice [London, UK] (ICPV), UNICANCER [Paris], Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Pathologie mammaire, and Département de médecine oncologique [Gustave Roussy]
Background: the MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. Methods: at inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. Discussion: beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. MyPeBS project is funded by the European Union’s Horizon 2020 research and innovation programme under grant agreement N°755394 and underwent a full external peer review process at this step. MyPeBS has received funding from the PHRC-K research-funding programme (17–154) for the conduct of the study in France. DPF is supported by the NIHR Biomedical Research Centre in Manchester (IS-BRC-1215–20007). FJG is supported by the NIHR Cambridge Biomedical Research Centre (BRC-1215–20014). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. XC is supported by grants from Instituto de Salud Carlos III FEDER (PI19/00007). MyPeBS is supported by the French health insurance systems (CNAM, MSA, MGEN, CPRPSNCF) for the covering of screening exams extra-costs, and by the Malakoff Humanis social protection group through the financing of the equipment of the recruiting centres with digital tablets to inform women about the study.