Breast Cancer Prevention and Screening Membership

NCT05258539 | Active Not Recruiting

• 2 other identifiers: APHP2115022021-A02665-36
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Breast cancer; Compliance; Risk Assessment; Cancer Risk Management Platform

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (1)

Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.

EXPERIMENTAL

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Woman diagnosed with breast cancer
• Woman under legal protection (guardianship, curatorship)
• Woman under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine UZAN, Pr

  Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: May 31, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2032
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)