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

Abstract

IntroductionPersonalised 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 analysisThe 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 disseminationThe 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 numberNCT03791008.

Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial

“…For practical reasons, this section reproduces in part the methods section of the published protocol [ 27 ]. See the study protocol for more details.…”

“…In order to reduce the time lag between evidence generation and implementation, we designed the DECIDO project, which aims to assess the acceptability and feasibility of offering personalized breast cancer screening and its integration into the normal clinical practice. This proof-of-concept study, the protocol of which was published elsewhere [ 27 ], assessed women’s attitudes, participation intentions, and satisfaction with personalized breast screening.…”

Barriers and Facilitators to the Implementation of a Personalized Breast Cancer Screening Program: Views of Spanish Health Professionals

“…At the same time, opportunistic screening in women younger than 50 years is widely used. This study is part of the DECIDO project, which aims to assess the acceptability and feasibility of offering personalized breast cancer screening and its integration in the usual clinical practice [12]. We recently conducted a qualitative study with focus groups of health professionals to explore the barriers and facilitators of implementing a risk-based breast cancer screening program in our National Health Service.…”

Shared decision-making in Spain in 2022: An updated revision of the current situation

“…Other studies have developed communication tools [36] and support materials aimed at facilitating the application of SDM by health professionals [37], but they did not assess their effectiveness. Two recent study protocols will assess the effectiveness of risk communication in breast cancer screening (DECIDO study) [38] and the integration of decision analysis in a decision tool for thromboprophylaxis during pregnancy (DASH-TOP) [39].…”