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Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial

Authors :
Marta Hernandez
Anna Pons-Rodriguez
Carles Forné Izquierdo
Jordi Vilaplana-Mayoral
Inés Cruz-Esteve
Isabel Sánchez-López
Mercè Reñé-Reñé
Cristina Cazorla
Marta Hernández-Andreu
Gisela Galindo-Ortego
Montserrat Llorens Gabandé
Celmira Laza-Vásquez
Pau Balaguer-Llaquet
Montserrat Martínez-Alonso
Montserrat Rué
Iván-David Benítez
Alexandra Bertran
Àngels Cardona
Misericòrdia Carles-Lavila
Cristina Cazorla-Sánchez
Núria Codern
Carles Forné-Izquierdo
Maria José Hernández-Andreu
Edelmir Iglesias
Montserrat Llorens-Gabandé
Maria José Pérez-Lacasta
Hèctor Perpiñán
Source :
BMJ Open, Vol 10, Iss 12 (2020)
Publication Year :
2020
Publisher :
BMJ Publishing Group, 2020.

Abstract

Introduction Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting.Methods and analysis The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40–50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student’s t-test will be used to obtain 95% CIs.Ethics and dissemination The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media.Trial registration number NCT03791008.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
10
Issue :
12
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.68dc74aca89b461e8bd77f06e4165612
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2020-044597