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      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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          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.

          Trial registration

          Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). Clinicaltrials.gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331

          Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12885-022-09484-6.

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          Most cited references53

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          Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries

          This article provides an update on the global cancer burden using the GLOBOCAN 2020 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer. Worldwide, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Female breast cancer has surpassed lung cancer as the most commonly diagnosed cancer, with an estimated 2.3 million new cases (11.7%), followed by lung (11.4%), colorectal (10.0 %), prostate (7.3%), and stomach (5.6%) cancers. Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and female breast (6.9%) cancers. Overall incidence was from 2-fold to 3-fold higher in transitioned versus transitioning countries for both sexes, whereas mortality varied <2-fold for men and little for women. Death rates for female breast and cervical cancers, however, were considerably higher in transitioning versus transitioned countries (15.0 vs 12.8 per 100,000 and 12.4 vs 5.2 per 100,000, respectively). The global cancer burden is expected to be 28.4 million cases in 2040, a 47% rise from 2020, with a larger increase in transitioning (64% to 95%) versus transitioned (32% to 56%) countries due to demographic changes, although this may be further exacerbated by increasing risk factors associated with globalization and a growing economy. Efforts to build a sustainable infrastructure for the dissemination of cancer prevention measures and provision of cancer care in transitioning countries is critical for global cancer control.
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            Using the framework method for the analysis of qualitative data in multi-disciplinary health research

            Background The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.
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              Process evaluation of complex interventions: Medical Research Council guidance

              Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
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                Author and article information

                Contributors
                sandrine.demontgolfier@u-pec.fr
                Journal
                BMC Cancer
                BMC Cancer
                BMC Cancer
                BioMed Central (London )
                1471-2407
                6 May 2022
                6 May 2022
                2022
                : 22
                : 507
                Affiliations
                [1 ]GRID grid.11318.3a, ISNI 0000000121496883, IRIS (UMR8156 CNRS & U997 INSERM), , Paris 13 University, ; Aubervilliers, France
                [2 ]GRID grid.5379.8, ISNI 0000000121662407, University of Manchester, ; Manchester, UK
                [3 ]GRID grid.508487.6, ISNI 0000 0004 7885 7602, Université de Paris, ; LIRAES F-75006, Paris, France
                [4 ]GRID grid.7849.2, ISNI 0000 0001 2150 7757, Université Lyon 1, ; P2S EA 4129, Centre Léon Bérard, F-69373 Lyon, France
                [5 ]AUSL - IRCCS Di Reggio Emilia, Reggio Emilia, Italy
                [6 ]GRID grid.14925.3b, ISNI 0000 0001 2284 9388, Institut Gustave Roussy, ; Villejuif, France
                [7 ]GRID grid.414003.2, ISNI 0000 0004 0644 9941, Assuta Medical Centers, ; Tel Aviv, Israel
                [8 ]GRID grid.7489.2, ISNI 0000 0004 1937 0511, Ben Gurion University, ; Beersheba, Israel
                [9 ]GRID grid.5335.0, ISNI 0000000121885934, University of Cambridge, ; Cambridge, UK
                [10 ]GRID grid.418119.4, ISNI 0000 0001 0684 291X, Institut Jules Bordet, ; Brussels, Belgium
                [11 ]GRID grid.411142.3, ISNI 0000 0004 1767 8811, IMIM (Hospital del Mar Medical Research Institute), ; Barcelona, Spain
                [12 ]European Cancer Leagues, Brussels, Belgium
                [13 ]Independent Cancer Patients’ Voice, London, UK
                [14 ]GRID grid.418189.d, ISNI 0000 0001 2175 1768, Unicancer, ; Paris, France
                [15 ]GRID grid.410511.0, ISNI 0000 0001 2149 7878, Paris Est Creteil University, ; Créteil, France
                Article
                9484
                10.1186/s12885-022-09484-6
                9073478
                35524202
                ef578d31-bae5-425a-91e3-c85a5c567d80
                © The Author(s) 2022

                Open AccessThis 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.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 17 February 2022
                : 2 April 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100010663, H2020 European Research Council;
                Award ID: 755394
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Oncology & Radiotherapy
                risk-stratification,breast cancer screening,psychological impact,comprehension,inequity,underserved populations,satisfaction

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