Breast Cancer Prevention and Screening Membership (AdDePi_KS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Questionnaire

Detailed Description

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. This approach would promote the implementation of measures that allow women to take a more active part in the decision-making process.

The current principle of the Cancer Risk Management Platform (CRMP) 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. Investigators believe that this approach will improve their understanding of the appropriation and dissemination of prevention practices for a better approach.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hopital Pitie Salpetriere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.	Other: Questionnaire; Telephone calls at 2, 3 and 5 years with : Lifestyle follow-up questionnaire.; Satisfaction questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patient with a compliance to the Personalized Prevention Plan established during 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.	Compliance will be measured at 2, 3 and 5 years from the initial risk assessment consultation

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit	2, 3 and 5 years from the initial risk assessment consultation
Proportion of participants who were active in sports when no sports were identified at the initial risk assessment visit	at 2, 3 and 5 years
Proportion of participants who quit smoking	at 2, 3 and 5 years
Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit	at 2, 3 and 5 years
Proportion of participants who changed their diets when an imbalance in diet was noted at the initial risk assessment visit	at 2, 3, and 5 years
Proportion of women who completed their screening as recommended following the CRMP consultation	at 2, 3 and 5 years
Proportion of women's satisfaction with the initial consultation	at 2, 3 and 5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine UZAN, Pr, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Compliance; Risk Assessment; Cancer Risk Management Platform
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: APHP211502; 2021-A02665-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
• IPD Sharing Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No