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

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.

Links

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  • Authors+Show Affiliations

    ,

    Department of Economics, University Rovira i Virgili, Reus, Spain. Research Group on Economic Evaluation and Health (GRAES), Reus, Spain. Research Centre on Industrial and Public Economics, (CREIP), Reus, Spain.

    ,

    Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain.

    ,

    Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain.

    ,

    Department of Economics, University Rovira i Virgili, Reus, Spain. Research Group on Economic Evaluation and Health (GRAES), Reus, Spain.

    ,

    Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain. Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain. Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.

    ,

    Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain. IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

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    Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.

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    Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.

    ,

    Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. Canary Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.

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    ÀreaQ, Evaluation and Qualitative Research, Barcelona, Spain. Nursing and Occupational Therapy School (EUIT), Terrassa, Universitat Autònoma de Barcelona, Barcelona, Spain.

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    Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.

    ,

    Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain. IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

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    Research Group on Economic Evaluation and Health (GRAES), Reus, Spain. Catalan Health Service, Tarragona Region, Tarragona, Spain. Medical School, University Rovira i Virgili, Reus, Spain.

    ,

    Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain. Department of Medicine, University of Lleida, Lleida, Spain.

    ,

    Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain. IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

    ,

    Research Group on Economic Evaluation and Health (GRAES), Reus, Spain. montse.rue@cmb.udl.cat. Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain. montse.rue@cmb.udl.cat. Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. montse.rue@cmb.udl.cat.

    Source

    Trials 18:1 2017 09 12 pg 426

    MeSH

    Access to Information
    Breast Neoplasms
    Choice Behavior
    Decision Making
    Female
    Health Knowledge, Attitudes, Practice
    Humans
    Mammography
    Mass Screening
    Middle Aged
    Pamphlets
    Patient Education as Topic
    Patient Participation
    Predictive Value of Tests
    Radiation Dosage
    Radiation Exposure
    Research Design
    Risk Assessment
    Risk Factors
    Spain

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    28899412

    Citation

    Carles, Misericòrdia, 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, vol. 18, no. 1, 2017, p. 426.
    Carles M, Martínez-Alonso M, Pons A, 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;18(1):426.
    Carles, M., Martínez-Alonso, M., Pons, A., Pérez-Lacasta, M. J., Perestelo-Pérez, L., Sala, M., ... Rué, M. (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(1), p. 426. doi:10.1186/s13063-017-2161-7.
    Carles 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 09 12;18(1):426. PubMed PMID: 28899412.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial. AU - Carles,Misericòrdia, AU - Martínez-Alonso,Montserrat, AU - Pons,Anna, AU - Pérez-Lacasta,Maria José, AU - Perestelo-Pérez,Lilisbeth, AU - Sala,Maria, AU - Vidal,Carmen, AU - Garcia,Montse, AU - Toledo-Chávarri,Ana, AU - Codern,Núria, AU - Feijoo-Cid,Maria, AU - Romero,Anabel, AU - Pla,Roger, AU - Soler-González,Jorge, AU - Castells,Xavier, AU - Rué,Montserrat, AU - ,, Y1 - 2017/09/12/ PY - 2017/07/01/received PY - 2017/08/25/accepted PY - 2017/9/14/entrez PY - 2017/9/14/pubmed PY - 2018/5/22/medline KW - Breast cancer KW - Decision aids KW - Early detection KW - Informed choice KW - Screening SP - 426 EP - 426 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://wwww.unboundmedicine.com/medline/citation/28899412/The_effect_of_information_about_the_benefits_and_harms_of_mammography_on_women's_decision_making:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2161-7 DB - PRIME DP - Unbound Medicine ER -