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

NCT05607849 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Nantes University hospital, Research Department

    collaborator UNKNOWN

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Cédric Rat, M.D. PhD. · Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France

  • Sandrine Hild, M.D. · Nantes University Hospital, Faculty of medicine, General Practice Department, Nantes, France

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-06-01
Completion
2025-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05607849 on ClinicalTrials.gov