NCT07120087

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

Evaluation of a Virtual Risk-reduction Intervention Among Women at Higher Than Average Risk of Breast Cancer in the European MyPeBS Screening Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,508 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 40 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

MyPREV is a prospective interventional cohort study. The study is based on an online educational, medical, and motivational intervention (webinar and online personalized clinical visit) dedicated to promoting and implementing lifestyle-based breast cancer risk-reduction measures among women identified in the MyPeBS trial as being at high or very high risk of breast cancer based on Polygenic risk score (PRS) and clinical scores. In MyPeBS, 34.4% of the women in the risk-based arm were estimated to be at high (33.03%) or very high (1.37%) to develop a breast cancer within 5 years. The study MyPREV plans to invite 3016 women (1821 in France and 1195 in Italy for the sites CPO and ISPRO). The expected participation rate is 50%, so around 1507 women (910 in France and 597 in Italy for the sites CPO and ISPRO). The intervention consist of a virtual webinar and an online personalized clinical visit where the personalized prevention plan will be created.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	Virual Webinar and online personalised clinical visit

Timeline

• Start date: 2026-02-19
• Primary completion: 2026-06-19
• Completion: 2027-06-01
• First posted: 2025-08-13
• Last updated: 2026-02-27

Locations

3 sites across 2 countries: France, Italy