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Active, Not Recruiting

NCT Number: NCT05258539

Breast Cancer Prevention and Screening Membership

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Pitié Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Telephone calls at 2, 3 and 5 years with :

  • Lifestyle follow-up questionnaire.
  • Satisfaction questionnaire.

Primary outcomes

  1. Proportion of patient with a compliance to the Personalized Prevention Plan established during the initial risk assessment consultation.

    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.

Secondary outcomes

  1. Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit

    Time frame: 2, 3 and 5 years from the initial risk assessment consultation

  2. Proportion of participants who were active in sports when no sports were identified at the initial risk assessment visit

    Time frame: at 2, 3 and 5 years

  3. Proportion of participants who quit smoking

    Time frame: at 2, 3 and 5 years

  4. Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit

    Time frame: at 2, 3 and 5 years

  5. Proportion of participants who changed their diets when an imbalance in diet was noted at the initial risk assessment visit

    Time frame: at 2, 3, and 5 years

  6. Proportion of women who completed their screening as recommended following the CRMP consultation

    Time frame: at 2, 3 and 5 years

  7. Proportion of women's satisfaction with the initial consultation

    Time frame: at 2, 3 and 5 years

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: AdDePi_KS

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Feb 28, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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