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Trials. 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.

Author information

1
Department of Economics, University Rovira i Virgili, Reus, Spain.
2
Research Group on Economic Evaluation and Health (GRAES), Reus, Spain.
3
Research Centre on Industrial and Public Economics, (CREIP), Reus, Spain.
4
Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain.
5
Lleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain.
6
Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain.
7
Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain.
8
Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
9
Epidemiology and Evaluation Department, Hospital del Mar, Barcelona, Spain.
10
IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.
11
Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.
12
Canary Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
13
ÀreaQ, Evaluation and Qualitative Research, Barcelona, Spain.
14
Nursing and Occupational Therapy School (EUIT), Terrassa, Universitat Autònoma de Barcelona, Barcelona, Spain.
15
Department of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
16
Catalan Health Service, Tarragona Region, Tarragona, Spain.
17
Medical School, University Rovira i Virgili, Reus, Spain.
18
Department of Medicine, University of Lleida, Lleida, Spain.
19
Research Group on Economic Evaluation and Health (GRAES), Reus, Spain. montse.rue@cmb.udl.cat.
20
Department of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain. montse.rue@cmb.udl.cat.
21
Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain. montse.rue@cmb.udl.cat.

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

PMID:
28899412
PMCID:
PMC5596499
DOI:
10.1186/s13063-017-2161-7
[Indexed for MEDLINE]
Free PMC Article

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