Alexandra Roux|Rachel Cholerton|Jonathan Sicsic|Nora Moumjid|David P. French|Paolo Giorgi Rossi|Corinne Balleyguier|Michal Guindy|Fiona J. Gilbert|Jean-Benoît Burrion|Xavier Castells|David Ritchie|Debbie Keatley|Camille Baron|Suzette Delaloge|Sandrine de Montgolfier
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
Université Sorbonne Paris Nord|Inserm|French National Centre for Scientific Research|University of Manchester|Université Paris Cité|Centre Léon Bérard|Claude Bernard University Lyon 1|University of Manchester|Azienda Sanitaria Unità Locale di Reggio Emilia|Istituti di Ricovero e Cura a Carattere Scientifico|Institut Gustave Roussy|Assuta Medical Center|University of Cambridge|Institut Jules Bordet|Hospital Del Mar|Hospital del Mar Research Institute|Municipal Institute for Medical Research|The Patients Association|UniCancer Group|UniCancer Group|Université Paris-Est Créteil
abstract background mypebs study ongoing randomised controlled trial testing whether riskstratified breast cancer screening strategy noninferior eventually superior standard agebased screening reducing incidence stage 2 cancers large european commissionfunded initiative aims include 85000 women aged 40 70 years without prior breast cancer previously identified high risk six countries belgium france italy israel spain uk specific work package within mypebs examines psychological socioeconomic ethical aspects new screening strategy compares womens reported data outcomes trial arms following issues general anxiety cancerrelated worry understanding breast cancer screening strategy informationseeking behaviour sociodemographic economic characteristics quality life risk perception intention change healthrelated behaviours satisfaction trial methods inclusion 3months 1year 4years woman participating mypebs asked fill online questionnaires descriptive statistics bivariate analyses subgroup comparisons analysis variations time performed appropriate tests assess differences arms multivariate regression models allow modelling different patient reported data outcomes comprehension information provided general anxiety cancer worry information seeking behaviour addition qualitative study 48 semistructured interviews conducted france uk women randomised riskstratified arm help understand participants acceptability comprehension trial experience risk assessment discussion beyond scientific medical objectives clinical study critical acknowledge consequences paradigm shift women indeed introducing riskbased screening relying individual biological differences also implies addressing nonbiological differences eg social status health literacy ethical perspective ensure equal access healthcare results present study facilitate making recommendations implementation end trial accompany potential change screening strategy trial registration study sponsor unicancer personalised breast screening mypebs clinicaltrialsgov 2018 available httpsclinicaltrialsgovct2shownct03672331 contact ccile vissac sabatier phd 33 01 73 79 77 58 ext 330142114293 contactmypebseu