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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: 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, on behalf of the InforMa Group

Published in: Trials | Issue 1/2017

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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.

Trial registration

ClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study.
Appendix
Available only for authorised users
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Metadata
Title
The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial
Authors
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
on behalf of the InforMa Group
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2161-7

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