NCT05607849

Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid

Shared Decision-making for Breast Cancer Screening in Primary Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20,000 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website Discutons-mammo.fr DEDICACES project 1. DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	The decidons ensemble (let's decide together) leaflet and the discutons-mammo.fr (let's talk about breast cancer screening) online tool.	The leaflet will include a link to access the discutons-mammo.fr DA aid tool, and will inform women about shared decision-making. The GPs of women who are sent the leaflet will also be sent a letter encouraging shared decision-making. This material will be sent 3 months after women have received their breast cancer screening invitation letter. Data related to primary and secondary objectives will be collected by questionnaire from the 2 groups. The questionnaire will be sent 2 months after participants are informed about the tool.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2022-11-07
• Last updated: 2024-11-15