Author, as appears in the article.: Carles, Misericòrida, Pérez-Lacasta, María José; Pla Farnòs, Roger Jesús

Department: Economia

URV's Author/s: CARLES LAVILA, MISERICÒRDIA; PÉREZ LACASTA, MARIA JOSÉ; PLA FARNÒS, ROGER JESÚS

Keywords: Càncer de mamella Mamografia Cancer de mama Mamografía Screening Breast Cancer Informed choice

Abstract: Background: The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening. Methods: A two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2–3 weeks after the intervention. Discussion: This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country.

Research group: Grup de Recerca en Anàlisi Econòmica i Salut

Thematic Areas: Economia i empresa Economía y empresa Economics and business

licence for use: https://creativecommons.org/licenses/by/3.0/es/

ISSN: 1745-6215

Author identifier: 0000-0003-3796-3014; 0000-0001-5906-5632; 0000-0002-3727-8933

Record's date: 2018-04-18

Journal volume: 18

Papper version: info:eu-repo/semantics/publishedVersion

Link to the original source: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2161-7

Article's DOI: 10.1186/s13063-017-2161-7

Entity: Universitat Rovira i Virgili

Journal publication year: 2017

Publication Type: Article Artículo Article