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The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial / Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern, Maria Feijoo-Cid, Anabel Romero, Roger Pla, Jorge Soler-González, Xavier Castells, Montserrat Rué email author and on behalf of the InforMa Group

Creator: Carles-Lavila, Misericòrdia, https://orcid.org/0000-0003-3796-3014 [autor].
Creators: Martínez-Alonso, Montserrat [autor] | Pons-Rodríguez, Anna [autor] | Pérez-Lacasta, María José [autor] | Perestelo-Pérez, Lilisbeth [autor] | Sala, Maria [autor] | Vidal, Carmen [autor] | Garcia, Montse [autor] | Toledo-Chávarri, Ana [autor] | Codern-Bové, Núria, https://orcid.org/0000-0003-0210-7488 [autor] | Feijoo-Cid, María [autor] | Romero, Anabel [autor] | Pla, Roger [autor] | Soler-González J [autor] | Castells, Xavier [autor] | Rué, Montserrat https://orcid.org/0000-0002-7862-9365 [autor] | InforMa | Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa.
Material type: ArticleArticleContent type: text Media type: informàtic Carrier type: recurs en líniaNew identifier: doi:: 10.1186/s13063-017-2161-7Subject(s): Càncer de mama | Cribratge (Medicina) | Diagnòstic precoç | Informació al pacient | Decisions compartides | Professors -- EUIT | Decisió, Presa de | Espanya | Mammography | Potential harms | Potential benefits | Informed choise | SpainGenre/Form: info:eu-repo/semantics/article | info:eu-repo/semantics/publishedVersionOnline resources: Enllaç permanent | Accés lliure pdf | Accés lliure (adreça alternativa) | Almetric: Cites | Dimensions: Cites | Google Acadèmic: Cites | PubMed: Cites | Semantic Scholar: Cites In: Trials 2017 SET;18(1):426Summary: 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. Trial registration ClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study.
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Item type Current library Collection Call number URL Status Notes Date due Barcode
Journal article Journal article Dipòsit Digital EUIT Internet En línia Text complet Not for loan Consulta en línia
Journal article Journal article Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa Internet En línia Text complet Not for loan Consulta en línia 0000101705897
Journal Journal Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa Internet En línia Text complet Not for loan 101263253

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