Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Sep 12;18(1):426.
doi: 10.1186/s13063-017-2161-7.

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  1   2   3 , Montserrat Martínez-Alonso  4 , Anna Pons  5 , Maria José Pérez-Lacasta  1   2 , Lilisbeth Perestelo-Pérez  6   7   8 , Maria Sala  8   9   10 , Carmen Vidal  11 , Montse Garcia  11 , Ana Toledo-Chávarri  8   12 , Núria Codern  13   14 , Maria Feijoo-Cid  15 , Anabel Romero  8   9   10 , Roger Pla  2   16   17 , Jorge Soler-González  5   18 , Xavier Castells  8   9   10 , Montserrat Rué  19   20   21 ; InforMa Group
Collaborators, Affiliations
Randomized Controlled Trial

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 et al. Trials. .

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.

Keywords: Breast cancer; Decision aids; Early detection; Informed choice; Screening.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Ethics Committees of the hospitals Universitari Arnau de Vilanova, in Lleida and Parc de Salut Mar in Barcelona (approval numbers 19/2014 and 2014/5998/I, respectively), and by the Scientific and Ethics Committee of the University Hospital Nuestra Señora de la Candelaria, in Tenerife (Canary Islands, Spain). The study is performed in accordance with Good Clinical Practice and the Declaration of Helsinki.

Informed consent will be obtained by phone after verifying that the inclusion criteria are met and it will be documented by the interviewer.

All participants will be assigned an ID number and all the questionnaires and datasets will be anonymized. Only the study team will have access to the document that links study ID with participant names. All the study files are electronic and will be stored on secure servers on password-protected computers.

Consent for publication

Not applicable

Competing interests

All authors have completed the International Committee of Medical Journal Editors (ICMJE) uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: funding from the Spanish Ministry of Health and the Biomedical Research Institute of Lleida (IRBLLEIDA) as described below; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Summary of enrollment, interventions, variable assessments, and timing for measurements (SPIRIT Figure). Allocation is established at the beginning of the study
See this image and copyright information in PMC

References

    1. Marmot MG, Altman DG, Cameron D, Dewar J, Thompson SG, Wilcox M. The benefits and harms of breast cancer screening: an independent review. Br J Cancer. 2013;108:2205–40. doi: 10.1038/bjc.2013.177. - DOI - PMC - PubMed
    1. Patient decision aids [Internet]. Ottawa: The Ottawa Hospital Research Institute; c2015 [cited 2017 Jun 25]. Available from: https://decisionaid.ohri.ca/. Accessed 4 Sept 2017.
    1. Steckelberg A, Hülfenhaus C, Haastert B, Mühlhauser I. Effect of evidence based risk information on “informed choice” in colorectal cancer screening: randomised controlled trial. BMJ. 2011;342:d3193. doi: 10.1136/bmj.d3193. - DOI - PMC - PubMed
    1. Hoffman RM, Elmore JG, Fairfield KM, Gerstein BS, Levin C, Pignone MP. Lack of shared decision making in cancer screening discussions. Results from a national survey. Am J Prev Med. 2014;47:251–9. doi: 10.1016/j.amepre.2014.04.011. - DOI - PubMed
    1. Toledo-Chávarri A, Rué M, Codern-Bové N, Carles-Lavila M, Perestelo-Pérez L, Pérez-Lacasta M, Feijoo-Cid M. A qualitative study on a decision aid for breast cancer screening : views from women and health professionals. Eur J Cancer Care. 2017;26:e12660. - PubMed

Publication types

MeSH terms

Associated data