Breast Cancer Prevention and Screening Membership

Breast Cancer Clinical Trial

— AdDePi_KS  

Official title:

Breast Cancer Prevention and Screening Membership

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258539
• Other study ID #: APHP211502
• Secondary ID: 2021-A02665-36
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: April 1, 2032

Study information

• Verified date: November 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Catherine UZAN, Pr
• Phone: 01 42 17 81 14
• Email: catherine.uzan[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: April 1, 2032
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Proportion of participants who quit smoking		at 2, 3 and 5 years
Secondary	Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit		at 2, 3 and 5 years
Secondary	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
Secondary	Proportion of women who completed their screening as recommended following the CRMP consultation		at 2, 3 and 5 years
Secondary	Proportion of women's satisfaction with the initial consultation		at 2, 3 and 5 years