Breast CancerAdDePi_KSNCT05258539
Breast Cancer Prevention and Screening Membership
A study testing Questionnaire in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to 1 Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Woman diagnosed with breast cancer
- Woman under legal protection (guardianship, curatorship)
- Woman under AME
Trial locations and contacts
1 site in 1 country.
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.
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire
- Keywords
- Breast cancer, Compliance, Risk Assessment, Cancer Risk Management Platform
- Medical subject headings
- Breast Neoplasms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Telephone calls at 2, 3 and 5 years with :
- Lifestyle follow-up questionnaire.
- Satisfaction questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment. | Experimental | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Compliance will be measured at 2, 3 and 5 years from the initial risk assessment consultation
Secondary outcomes (7)
Proportion of participants with weight loss when overweight was identified at the initial risk assessment visit
Measured: 2, 3 and 5 years from the initial risk assessment consultation
Proportion of participants who were active in sports when no sports were identified at the initial risk assessment visit
Measured: at 2, 3 and 5 years
Proportion of participants who quit smoking
Measured: at 2, 3 and 5 years
Proportion of participants who changed their alcohol consumption when it was excessive at the initial risk assessment visit
Measured: at 2, 3 and 5 years
Proportion of participants who changed their diets when an imbalance in diet was noted at the initial risk assessment visit
Measured: at 2, 3, and 5 years
Proportion of women who completed their screening as recommended following the CRMP consultation
Measured: at 2, 3 and 5 years
Proportion of women's satisfaction with the initial consultation
Measured: at 2, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start31 May 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine UZAN, Pr, Principal investigator, Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258539
- Sponsor's protocol ID
- APHP211502
- Other IDs
- 2021-A02665-36
- Acronym
- AdDePi_KS
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Prevention and Screening Membership
- ClinicalTrials.gov ID
- NCT05258539
- Acronym / sponsor ID
- AdDePi_KS / APHP211502
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Compliance, Risk Assessment, Cancer Risk Management Platform
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment. | Experimental | Other: Questionnaire |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Woman diagnosed with breast cancer
- Woman under legal protection (guardianship, curatorship)
- Woman under AME
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTelephone calls at 2, 3 and 5 years with : * Lifestyle follow-up questionnaire. * Satisfaction questionnaire. | Other | Women aged 18 to 85 years who come to the CRMP for a breast cancer risk assessment. |
Primary outcome
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.
7 secondary outcomes
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
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
Proportion of participants who quit smoking
Time frame: at 2, 3 and 5 years
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
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
Proportion of women who completed their screening as recommended following the CRMP consultation
Time frame: at 2, 3 and 5 years
Proportion of women's satisfaction with the initial consultation
Time frame: at 2, 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine UZAN, Pr principal investigator
Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.