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Breast Cancer Prevention and Screening Membership (AdDePi_KS)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Compliance, Risk Assessment, Cancer Risk Management Platform

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pitié SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit
Proportion of participants who were active in sports when no sports were identified at the initial risk assessment visit
Proportion of participants who quit smoking
Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit
Proportion of participants who changed their diets when an imbalance in diet was noted at the initial risk assessment visit
Proportion of women who completed their screening as recommended following the CRMP consultation
Proportion of women's satisfaction with the initial consultation

Full Information

First Posted
February 17, 2022
Last Updated
June 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05258539
Brief Title
Breast Cancer Prevention and Screening Membership
Acronym
AdDePi_KS
Official Title
Breast Cancer Prevention and Screening Membership
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Compliance, Risk Assessment, Cancer Risk Management Platform

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment.
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Telephone calls at 2, 3 and 5 years with : Lifestyle follow-up questionnaire. Satisfaction questionnaire.
Primary Outcome Measure Information:
Title
Proportion of patient with a compliance to the Personalized Prevention Plan established during 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.
Time Frame
Compliance will be measured at 2, 3 and 5 years from the initial risk assessment consultation
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Proportion of participants who quit smoking
Time Frame
at 2, 3 and 5 years
Title
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
Title
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
Title
Proportion of women who completed their screening as recommended following the CRMP consultation
Time Frame
at 2, 3 and 5 years
Title
Proportion of women's satisfaction with the initial consultation
Time Frame
at 2, 3 and 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine UZAN, Pr
Phone
01 42 17 81 14
Email
catherine.uzan@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Diarietou GUEYE, Dr
Phone
01 40 77 99 45
Email
diarietou.ndiaye-gueye@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine UZAN, Pr
Organizational Affiliation
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine UZAN, Pr
Phone
01 42 17 81 14
Email
catherine.uzan@aphp.fr
First Name & Middle Initial & Last Name & Degree
Diarietou GUEYE, Dr
Phone
01 40 77 99 45
Email
diarietou.ndiaye-gueye@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Breast Cancer Prevention and Screening Membership

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