The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial

Carles, Misericòrdia; Martínez-Alonso, Montserrat; Pons, Anna; Pérez-Lacasta, Maria José; Perestelo-Pérez, Lilisbeth; Sala Serra, Maria; Vidal, Carmen; García, Montse; Toledo-Chávarri, Ana; Codern Bové, Núria; Feijoo Cid, Maria; Romero, Anabel; Pla, Roger; Soler-González, Jorge; Castells, Xavier; Rué, Montserrat; InforMa Group

The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial

Mostra el registre complet Registre parcial de l'ítem

dc.contributor.author Carles, Misericòrdiaca
dc.contributor.author Martínez-Alonso, Montserratca
dc.contributor.author Pons, Annaca
dc.contributor.author Pérez-Lacasta, Maria Joséca
dc.contributor.author Perestelo-Pérez, Lilisbethca
dc.contributor.author Sala Serra, Mariaca
dc.contributor.author Vidal, Carmenca
dc.contributor.author García, Montseca
dc.contributor.author Toledo-Chávarri, Anaca
dc.contributor.author Codern Bové, Núriaca
dc.contributor.author Feijoo Cid, Mariaca
dc.contributor.author Romero, Anabelca
dc.contributor.author Pla, Rogerca
dc.contributor.author Soler-González, Jorgeca
dc.contributor.author Castells, Xavierca
dc.contributor.author Rué, Montserratca
dc.contributor.author InforMa Groupca
dc.date.accessioned 2018-07-27T07:33:27Z
dc.date.available 2018-07-27T07:33:27Z
dc.date.issued 2017
dc.description.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.
dc.format.mimetype application/pdf
dc.identifier.citation Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M. et al. The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial. Trials. 2017 Sep 12;18(1):426. DOI: 10.1186/s13063-017-2161-7
dc.identifier.doi http://dx.doi.org/10.1186/s13063-017-2161-7
dc.identifier.issn 1745-6215
dc.identifier.uri http://hdl.handle.net/10230/35313
dc.language.iso eng
dc.publisher BioMed Centralca
dc.relation.ispartof Trials. 2017 Sep 12;18(1):426
dc.rights Copyright © The Author(s). 2017. Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by/4.0/
dc.subject.keyword Breast cancer
dc.subject.keyword Decision aids
dc.subject.keyword Early detection
dc.subject.keyword Informed choice
dc.subject.keyword Screening
dc.subject.other Mama -- Càncer -- Prevenció
dc.subject.other Mama -- Radiografia
dc.title The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trialca
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

Col·leccions

Articles (Hospital del Mar Research Institute)