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...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2017-09-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2161-7 |
| _version_ | 1818850839830200320 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Misericòrdia Carles |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-19T06:55:31Z |
| format | Article |
| id | doaj.art-edb6060555a245b5b49fa1c834997298 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T06:55:31Z |
| publishDate | 2017-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-edb6060555a245b5b49fa1c8349972982022-12-21T20:31:32ZengBMCTrials1745-62152017-09-011811810.1186/s13063-017-2161-7The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trialMisericòrdia Carles0Montserrat Martínez-Alonso1Anna Pons2Maria José Pérez-Lacasta3Lilisbeth Perestelo-Pérez4Maria Sala5Carmen Vidal6Montse Garcia7Ana Toledo-Chávarri8Núria Codern9Maria Feijoo-Cid10Anabel Romero11Roger Pla12Jorge Soler-González13Xavier Castells14Montserrat Rué15on behalf of the InforMa GroupDepartment of Economics, University Rovira i VirgiliDepartment of Basic Medical Sciences, University of Lleida-IRBLLEIDALleida Biomedical Research Institute (IRBLLEIDA)Department of Economics, University Rovira i VirgiliEvaluation Unit of the Canary Islands Health Service (SESCS)Health Services Research on Chronic Patients Network (REDISSEC)Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELLCancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELLHealth Services Research on Chronic Patients Network (REDISSEC)ÀreaQ, Evaluation and Qualitative ResearchDepartment of Nursing, Faculty of Medicine, Universitat Autònoma de BarcelonaHealth Services Research on Chronic Patients Network (REDISSEC)Research Group on Economic Evaluation and Health (GRAES)Lleida Biomedical Research Institute (IRBLLEIDA)Health Services Research on Chronic Patients Network (REDISSEC)Research Group on Economic Evaluation and Health (GRAES)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.http://link.springer.com/article/10.1186/s13063-017-2161-7ScreeningBreast cancerInformed choiceEarly detectionDecision aids |
| spellingShingle | 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 The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial Trials Screening Breast cancer Informed choice Early detection Decision aids |
| title | The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial |
| title_full | The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial |
| title_fullStr | The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial |
| title_full_unstemmed | The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial |
| title_short | The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial |
| title_sort | effect of information about the benefits and harms of mammography on women s decision making study protocol for a randomized controlled trial |
| topic | Screening Breast cancer Informed choice Early detection Decision aids |
| url | http://link.springer.com/article/10.1186/s13063-017-2161-7 |
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