The effect of information about the benefits and harms of mammography on women's decision-making : study protocol for a randomized controlled trial
Carles-Lavila, Misericòrdia (Universitat Rovira i Virgili)
Martínez-Alonso, Montserrat (Universitat de Lleida)
Pons, Anna (Institut de Recerca Biomèdica de Lleida)
Pérez-Lacasta, María José (Universitat Rovira i Virgili)
Perestelo-Pérez, Lilisbeth (Health Services Research on Chronic Patients Network (REDISSEC), Madrid)
Sala, Maria (Institut Hospital del Mar d'Investigacions Mèdiques)
Vidal, Carmen (Institut d'Investigació Biomèdica de Bellvitge)
Garcia, Montse (Institut d'Investigació Biomèdica de Bellvitge)
Toledo-Chávarri, Ana (Canary Islands Foundation of Health Research (FUNCANIS), Tenerife)
Codern-Bové, Núria (ÀreaQ, Evaluation and Qualitative Research, Barcelona)
Feijoo Cid, Maria (Universitat Autònoma de Barcelona. Departament d'Infermeria)
Romero, Anabel (Institut Hospital del Mar d'Investigacions Mèdiques)
Pla, Roger (Universitat Rovira i Virgili)
Soler-González, Jorge (Universitat de Lleida. Departament de Medicina)
Castells, Xavier (Institut Hospital del Mar d'Investigacions Mèdiques)
Rué, Montserrat (Universitat de Lleida)

Data:	2017
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.
Ajuts:	Instituto de Salud Carlos III PI14/00113
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Screening ; Breast cancer ; Informed choice ; Early detection ; Decision aids
Publicat a:	Trials, Vol. 18 (september 2017) , ISSN 1745-6215

DOI: 10.1186/s13063-017-2161-7
PMID: 28899412

8 p, 505.7 KB

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