Autor segons l'article: Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M, Vidal C, Garcia M, Toledo-Chávarri A, Codern N, Feijoo-Cid M, Romero A, Pla R, Soler-González J, Castells X, Rué M, InforMa Group
Departament: Medicina i Cirurgia Economia
Autor/s de la URV: Carles Lavila, Misericòrdia / Pérez Lacasta, Maria José / Pla Farnòs, Roger Jesús
Paraules clau: Screening Informed choice Elecció informada a l'entorn sanitari: disseminació de la informació entre els consumidors per la seva presa de decisions Elaboració de materials per ajudar a prendre decisions informades Early detection Decision aids Breast cancer
Resum: 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.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.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.ClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.
Àrees temàtiques: Saúde coletiva Psicología Pharmacology (medical) Odontología Nutrição Medicine, research & experimental Medicine (miscellaneous) Medicina iii Medicina ii Medicina i Materiais Interdisciplinar Engenharias iv Enfermagem Educação física Ciências biológicas iii Ciências biológicas ii Ciências ambientais Biotecnología Administração pública e de empresas, ciências contábeis e turismo
Accès a la llicència d'ús: https://creativecommons.org/licenses/by/3.0/es/
ISSN: 17456215
Adreça de correu electrònic de l'autor: rogerjesus.pla@urv.cat misericordia.carles@urv.cat mariajose.perez@urv.cat
Identificador de l'autor: 0000-0002-3727-8933 0000-0003-3796-3014 0000-0001-5906-5632
Data d'alta del registre: 2024-06-28
Versió de l'article dipositat: info:eu-repo/semantics/publishedVersion
Enllaç font original: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2161-7#citeas
URL Document de llicència: http://repositori.urv.cat/ca/proteccio-de-dades/
Referència a l'article segons font original: Trials. 18 (426): 1-8
Referència de l'ítem segons les normes APA: Carles M, Martínez-Alonso M, Pons A, Pérez-Lacasta MJ, Perestelo-Pérez L, Sala M, Vidal C, Garcia M, Toledo-Chávarri A, Codern N, Feijoo-Cid M, Romero (2017). The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.. Trials, 18(426), 1-8. DOI: 10.1186/s13063-017-2161-7
DOI de l'article: 10.1186/s13063-017-2161-7
Entitat: Universitat Rovira i Virgili
Any de publicació de la revista: 2017
Tipus de publicació: Journal Publications
Repositori URV