Evaluation of an Online Intervention to Educate Women at High Risk of Breast Cancer on How to Help Reduce Their Risk.

NCT07120087 | Recruiting

• 1 other identifier: UC-BCG-2508
• Study Type: interventional
• Target: 1,508
• Locations: 2 countries
• Sites: 3

Brief Summary

Breast cancer remains the most common cancer among women and a major cause of death despite advances in screening and treatment. Current screening programs are not personalized and are experiencing declining participation. A promising strategy for breast cancer control would be to implement risk-based prevention and early screening, targeting individuals at high risk of developing breast cancer, in order to improve chances of cure and reduce the need for more intensive treatments. The MyPeBS study was designed to assess whether personalized breast cancer screening (based on an individual's risk of developing breast cancer) is as effective as, or more effective than, current standard screening. Lifestyle interventions involving changes in diet or physical activity, for example, have been shown to be effective in reducing the risk of developing breast cancer, whether low or high. The MyPeBS study evaluates personalized screening but offers limited information on breast cancer prevention. MyPREV is a project that aims to assess the feasibility and impact of a personalized online program on breast cancer risk reduction measures. This program is offered to women at high risk of developing breast cancer as part of the European MyPeBS screening study. The main objective is to evaluate adherence to a personalized, online breast cancer prevention program focused on lifestyle and its acceptance among women at high or very high risk of developing cancer who participated in the MyPeBS study.

Conditions

Breast Cancer

Keywords

Prevent and treat - breast cancer screening

Outcome Measures

Primary Outcomes (1)

• Acceptance

  To assess the acceptance of a full, targeted, online, educational and motivational intervention on breast cancer risk reduction measures among women who took part in MyPeBS and were identified to have a high or very high risk of breast cancer.

  From start of the inclusion up to the end of inclusions

Secondary Outcomes (7)

• Prevalence of risk reduction targets

  From start of the inclusion up to the end of inclusions

• WCRF

  At 3 months, 1 year

• Strate-Trait Anxiety Inventory - State (STAI-S)

  At baseline

• Subject knowledge and perception of knowledge

  At baseline, 1 year

• Subject anxiety

  At baseline, 1 year

Study Arms (1)

intervention

OTHER

intervention

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

Virual Webinar and online personalised clinical visit

intervention

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female (whether born female or not)
• Women aged 40 to 74 years (inclusive)
• Women able to express their non-opposition to participate in the intervention
• Women who were assessed as being at high (≥≥1.67% - 5.9%) or very high (≥≥6%) risk of invasive breast cancer at 5 years in the MyPeBS study

You may not qualify if:

• \. Women who developed a breast cancer during their follow-up in the MyPeBS study

Sponsors & Collaborators

• UNICANCER: lead
• European Union: collaborator

Study Sites (3)

Centre Médical et Dentaire de Lyon MGEN

Lyon, 69003, France

RECRUITING

Gustave Roussy

Villejuif, France

NOT YET RECRUITING

AOU Città della Salute e della Scienza - CPO PiedmontSSD Epidemiologia e Screening

Torino, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

Locations

IT (1); FR (2)