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
. 2023 Apr 24:13:1128467.
doi: 10.3389/fonc.2023.1128467. eCollection 2023.

Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol

Sandrine Hild  1 , Delphine Teigné  1   2 , Emilie Ferrat  3 , Anne-Sophie Banaszuk  4 , Karine Berquet  4 , Aline Lebon  4 , Emmanuelle Bataille  5 , France Nanin  5 , Aurélie Gaultier  1   6 , Cédric Rat  1   7
Affiliations

Breast cancer: a randomized controlled trial assessing the effect of a decision aid on mammography screening uptake: study protocol

Sandrine Hild et al. Front Oncol. .

Abstract

Introduction: Breast cancer (BC) is the primary cancer among women. The World Health Organization recommends a bilateral screening mammogram every 2 years for women aged 50 to 74 years. However, it has been shown that there is an absence of information about the benefits and risks of screening. Shared medical decision-making is important to ensure patients are involved in the decision process. Decision aids can facilitative this decision-making process. This article presents a protocol to evaluate the effect of a decision aid on participation rates in the French organized BC screening program.

Methods and analysis: Design and setting. The design is a 2 arm randomized controlled study, performed in the Pays de la Loire region (French West Coast). Randomization will be based on general medicine practices (Primary Care).

Participants: Women aged between 50 and 74 years, eligible for BC screening. In this region, there are 75000 women, and 2800 general practitioners eligible for recruitment.

Intervention: In the « Decision aid for organized cancer screening » arm, the intervention will distribute invitation letters to eligible women combined with the provision of decision aid to these women and their general practitioners and an incentive to implement shared medical decision-making. In the « Standard organized cancer screening » arm, only the screening invitation will be sent to eligible women.

Primary endpoint: BC screening participation rates will be assessed after an 18-month follow-up period.

Statistical analysis: In this non-inferiority trial, the percentage of women who are up-to-date with their screening at 18 months after the intervention will be compared across arms using a generalized mixed linear model.

Discussion: The research team expect to demonstrate that providing a better explanation of the benefits and risks of BC screening is not at odds with screening participation. The study results should help policy makers thinking about implementing shared medical decision-making within the framework of organized BC screening programs in the future.

Ethics and dissemination: On 6 December 2021, the protocol received a favorable opinion from the French Committee for the Protection of Persons (2021-A01583-38). This study is registered with ClinicalTrials.gov, number NCT05607849. (Version 1, November 7, 2022; https://www.clinicaltrials.gov/ct2/show/NCT05607849). The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.

Keywords: breast cancer screening; decision aid; general practitioner; organized screening; randomized controlled trial; shared medical decision making.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study design.
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. . Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin (2021) 71(3):209−49. - PubMed
    1. International Agency for Research on Cancer. World Health Organization. Global Cancer Observatory . Estimated cancer incidence, mortality and prevalence worldwide in 2020: breast cancer. (Lyon France: World Health Organization; ). (2020).
    1. Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography. Cochrane Database Syst Rev (2013) 2013(6):CD001877. doi: 10.1002/14651858.CD001877.pub5 - DOI - PMC - PubMed
    1. Myers ER, Moorman P, Gierisch JM, Havrilesky LJ, Grimm LJ, Ghate S, et al. . Benefits and harms of breast cancer screening: a systematic review. JAMA. 20 oct (2015) 314(15):1615. doi: 10.1001/jama.2015.13183 - DOI - PubMed
    1. Tabár L, Gad A, Holmberg LH, Ljungquist U, Fagerberg CJG, Baldetorp L, et al. . Reduction in mortality from breast cancer after mass screening with mammography. Lancet (1985) 325(8433):829−32. doi: 10.1016/S0140-6736(85)92204-4 - DOI - PubMed

Associated data