Ireland
--:--IST
Active, not recruiting Not applicable

Breast Cancer Prevention and Screening Membership

NCT05258539 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-05-31
Last updated
2025-08-22

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Questionnaire

Questionnaire: Telephone calls at 2, 3 and 5 years with : * Lifestyle follow-up questionnaire. * Satisfaction questionnaire.

Study summary

The AdDePi-KS project aims to contribute to the renovation of the breast cancer screening program. In order to improve information to women on breast cancer risk factors and their participation in organized screening, but also to reduce the incidence of the disease, the prevention policy currently in place could be adapted and optimized based on the assessment of women's individual risk factors.

The current principle of the platform is to offer women a breast cancer risk assessment and prevention consultation with a clinical examination and the use of three breast cancer risk calculation models: Tyrer Cuzick (TC) Mammorisk© (MMR) and CANRISK. In parallel to the use of these three softwares, the Eisinger and Manchester scores are also calculated to evaluate the indication of an oncogenetic consultation. At the end of this analysis, a personalized prevention plan (PPP) proposal, adaptable by the practitioner by shared decision with the consultant, is generated and proposed. The risk assessment and the monitoring strategy are explained to the consultant and when "actionable" risk factors are identified, personalized assistance is proposed (dietary consultation, smoking consultation, distribution of information documents, particularly on physical activity).

The objective of this study is to evaluate the impact of the consultation in the long term, in particular on compliance with the recommended monitoring methods and on the "actionable" personal risk factors. For this purpose, investigators propose to set up follow-up questionnaires at 2, 3 and 5 years. These questionnaires will also make it possible to monitor over time how the notion of risk is perceived and how this could influence primary (action on risk factors) and secondary (screening) prevention behaviors. Thus, by accompanying the objectives and methods of prevention in a genuine health democracy process, investigators will be able to identify certain obstacles and levers linked to the implementation of these actions.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Woman aged 18-85 years who comes to the Cancer Risk Management Platform (CRMP) for a breast cancer risk assessment * A woman who has signed an informed consent form * Woman who is a beneficiary or entitled person of a social security plan Exclusion Criteria: * Woman diagnosed with breast cancer * Woman under legal protection (guardianship, curatorship) * Woman under AME

Primary outcome measure(s)

  • Proportion of patient with a compliance to the Personalized Prevention Plan established during the initial risk assessment consultation. — Compliance will be measured at 2, 3 and 5 years from the initial risk assessment consultation
    Modification of at least one behavior of the women with respect to certain actionable risk factors: alcohol consumption, overweight, sedentary lifestyle, smoking, fiber consumption.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Pitié Salpêtrière Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05258539 on ClinicalTrials.gov ↗ ← All trials in France