Clinical trial · Interventional
Breast Cancer Prevention and Screening Membership
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.
- interventionNames
- Other: Questionnaire
Primary outcomes (1)
- measure
- Proportion of patient with a compliance to the Personalized Prevention Plan established during the initial risk assessment consultation.
- timeFrame
- Compliance will be measured at 2, 3 and 5 years from the initial risk assessment consultation
- description
- Modification of at least one behavior of the women with respect to certain actionable risk factors: alcohol consumption, overweight, sedentary lifestyle, smoking, fiber consumption.
Secondary outcomes (7)
- measure
- Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available