Hôpital Pitié Salpêtrière
Paris, 75013, France
NCT Number: NCT05258539
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.
This study is active but is not currently recruiting participants.
18 year–85 year
Female
Interventional
Not applicable
Paris, 75013, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Telephone calls at 2, 3 and 5 years with :
Time frame: 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.
Time frame: 2, 3 and 5 years from the initial risk assessment consultation
Time frame: at 2, 3 and 5 years
Time frame: at 2, 3 and 5 years
Time frame: at 2, 3 and 5 years
Time frame: at 2, 3, and 5 years
Time frame: at 2, 3 and 5 years
Time frame: at 2, 3 and 5 years
Assistance Publique - Hôpitaux de Paris
Other
Acronym: AdDePi_KS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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