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Breast Cancer Prevention and Screening Membership

NCT05258539 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2025-08-22

No results posted yet for this 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.

Conditions

Interventions

OTHER

Questionnaire

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Catherine UZAN, Pr · Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2027-04-01
Completion
2032-04-01

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT05258539 on ClinicalTrials.gov