Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial

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• dc.contributor.author Roux, Alexandra
• dc.contributor.author Cholerton, Rachel
• dc.contributor.author Sicsic, Jonathan
• dc.contributor.author Moumjid, Nora
• dc.contributor.author French, David P.
• dc.contributor.author Rossi, Paolo G.
• dc.contributor.author Balleyguier, Corinne
• dc.contributor.author Guindy, Michal
• dc.contributor.author Gilbert, Fiona J.
• dc.contributor.author Burrion, Jean-Benoit
• dc.contributor.author Castells, Xavier
• dc.contributor.author Ritchie, David
• dc.contributor.author Keatley, Debbie
• dc.contributor.author Baron, Camille
• dc.contributor.author Delaloge, Suzette
• dc.contributor.author de Montgolfier, Sandrine
• dc.date.accessioned 2022-10-10T06:36:09Z
• dc.date.available 2022-10-10T06:36:09Z
• dc.date.issued 2022
• dc.description.abstract 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.
• dc.description.sponsorship 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.
• dc.format.mimetype application/pdf
• dc.identifier.citation Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Rossi PG, et al. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial. BMC Cancer. 2022 May 6;22(1): 507. DOI: 10.1186/s12885-022-09484-6
• dc.identifier.doi http://dx.doi.org/10.1186/s12885-022-09484-6
• dc.identifier.issn 1471-2407
• dc.identifier.uri http://hdl.handle.net/10230/54321
• dc.language.iso eng
• dc.publisher BioMed Central
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/755394
• dc.rights © Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Rossi PG, 2022. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Breast cancer screening
• dc.subject.keyword Comprehension
• dc.subject.keyword Inequity
• dc.subject.keyword Psychological impact
• dc.subject.keyword Risk-stratification
• dc.subject.keyword Satisfaction
• dc.subject.keyword Underserved populations
• dc.title Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion