Clinical trial NCT05258539: Breast Cancer Prevention and Screening Membership
Official title: Breast Cancer Prevention and Screening Membership
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Compliance
Risk Assessment
Cancer Risk Management Platform
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit
timeFrame: 2, 3 and 5 years from the initial risk assessment consultation
measure: Proportion of participants who were active in sports when no sports were identified at the initial risk assessment visit
timeFrame: at 2, 3 and 5 years
measure: Proportion of participants who quit smoking
timeFrame: at 2, 3 and 5 years
measure: Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit
timeFrame: at 2, 3 and 5 years
measure: Proportion of participants who changed their diets when an imbalance in diet was noted at the initial risk assessment visit
timeFrame: at 2, 3, and 5 years
measure: Proportion of women who completed their screening as recommended following the CRMP consultation
timeFrame: at 2, 3 and 5 years
measure: Proportion of women's satisfaction with the initial consultation
timeFrame: at 2, 3 and 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
name: Catherine UZAN, Pr
role: PRINCIPAL_INVESTIGATOR
References: