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

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, 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

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://ichgcp.net/clinical-trials-registry/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

Keywords: Breast cancer screening; Comprehension; Inequity; Psychological impact; Risk-stratification; Satisfaction; Underserved populations.

Conflict of interest statement

The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Design of MyPeBS and timing of questionnaire administration. *The baseline mammogram can be performed before or after randomization. If participants had a mammogram in the year prior to recruitment, they do not have to do new one. Psycho-social questionnaires: Q1: STAI (state of anxiety), Q2: Lerman cancer worry scale, Q3: Comprehension, Q4: Information-seeking behaviour and health literacy, Q5: Risk perception, Q6: Quality of life (EQ-5D), Q7: Satisfaction, Q8: Socio-demographic and economic status

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