Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial
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 i...
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oai:doaj.org-article:68dc74aca89b461e8bd77f06e41656122021-11-20T15:30:04ZFeasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial10.1136/bmjopen-2020-0445972044-6055https://doaj.org/article/68dc74aca89b461e8bd77f06e41656122020-12-01T00:00:00Zhttps://bmjopen.bmj.com/content/10/12/e044597.fullhttps://doaj.org/toc/2044-6055Introduction 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.Marta HernandezAnna Pons-RodriguezCarles Forné IzquierdoJordi Vilaplana-MayoralInés Cruz-EsteveIsabel Sánchez-LópezMercè Reñé-ReñéCristina CazorlaMarta Hernández-AndreuGisela Galindo-OrtegoMontserrat Llorens GabandéCelmira Laza-VásquezPau Balaguer-LlaquetMontserrat Martínez-AlonsoMontserrat RuéIván-David BenítezAlexandra BertranÀngels CardonaMisericòrdia Carles-LavilaCristina Cazorla-SánchezNúria CodernCarles Forné-IzquierdoMaria José Hernández-AndreuEdelmir IglesiasMontserrat Llorens-GabandéMaria José Pérez-LacastaHèctor PerpiñánBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 10, Iss 12 (2020) |
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Medicine R 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 Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| description |
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. |
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article |
| author |
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 |
| author_facet |
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 |
| author_sort |
Marta Hernandez |
| title |
Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| title_short |
Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| title_full |
Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| title_fullStr |
Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| title_full_unstemmed |
Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial |
| title_sort |
feasibility and acceptability of personalised breast cancer screening (decido study): protocol of a single-arm proof-of-concept trial |
| publisher |
BMJ Publishing Group |
| publishDate |
2020 |
| url |
https://doaj.org/article/68dc74aca89b461e8bd77f06e4165612 |
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