Online education plus personalized prevention plan for women at high breast cancer risk.
Evaluation of a Virtual Risk-reduction Intervention Among Women at Higher Than Average Risk of Breast Cancer in the European MyPeBS Screening Trial
This project tests an online webinar and a personalized virtual clinical visit to teach women at high 5-year breast cancer risk how to lower their risk through lifestyle changes and a tailored prevention plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1508 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | Female |
| Sponsor | Unicancer Academic / other |
| Locations | 3 sites (Lyon and 2 other locations) |
| Trial ID | NCT07120087 on ClinicalTrials.gov |
What this trial studies
MyPREV is a prospective interventional cohort targeting women identified as high or very high 5-year breast cancer risk within the MyPeBS program using polygenic risk scores and clinical risk factors. The intervention combines a virtual educational webinar with an online personalized clinical visit during which a tailored lifestyle-based prevention plan is created. The study plans to invite 3,016 MyPeBS participants from French and Italian sites and expects about 50% participation (~1,507 women). Outcomes will focus on implementation of prevention measures and engagement with the personalized plan over the follow-up period.
Who should consider this trial
Good fit: Women aged 40 to 74 who participated in MyPeBS, were classified as high or very high 5-year breast cancer risk, can provide consent, and have not been diagnosed with breast cancer are eligible.
Not a fit: Women who developed breast cancer during MyPeBS follow-up, those at average or low risk, or those unable or unwilling to access or follow online interventions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the intervention could increase uptake of risk-reducing lifestyle changes and personalized prevention, potentially lowering future breast cancer incidence and the need for intensive treatments.
How similar studies have performed: Lifestyle interventions have demonstrated effectiveness in reducing breast cancer risk, but online personalized prevention programs for high-risk women are a more recent approach with emerging evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female (whether born female or not) 2. Women aged 40 to 74 years (inclusive) 3. Women who have participated in, or are participating in the MyPeBS study and who fulfilled all the inclusion and non-inclusion criteria for the MyPeBS study. 4. Women able to express their non-opposition to participate in the intervention 5. 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 Exclusion Criteria: 1\. Women who developed a breast cancer during their follow-up in the MyPeBS study
Where this trial is running
Lyon and 2 other locations
- Centre Médical et Dentaire de Lyon MGEN — Lyon, 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.