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NCT Number: NCT07120087

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

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.

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Key information

Conditions

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

Age range

40 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Médical et Dentaire de Lyon MGEN, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female (whether born female or not)
  • Women aged 40 to 74 years (inclusive)
  • 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.
  • 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

Exclusion criteria

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

Treatment and study plan

Intervention

Behavioral

Virual Webinar and online personalised clinical visit

Primary outcomes

  1. Acceptance

    Time frame: From start of the inclusion up to the end of inclusions

    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.

Secondary outcomes

  1. Prevalence of risk reduction targets

    Time frame: From start of the inclusion up to the end of inclusions

    Assess the prevalence of breast cancer risk reduction targets (potentially modifiable factors) among women willing to participate

  2. WCRF

    Time frame: At 3 months, 1 year

    Assess the participants' progress in modifying some of their behaviours according to the WCRF score at 3 months and 1 year

  3. Strate-Trait Anxiety Inventory - State (STAI-S)

    Time frame: At baseline

    Evaluate patient characteristics (age, country, education level, professional occupation, Strate-Trait Anxiety Inventory [STAI] score at baseline in MyPeBS, level of breast cancer risk) associated with participation or non-participation in the proposed program and receipt of the proposed intervention

  4. Subject knowledge and perception of knowledge

    Time frame: At baseline, 1 year

    Evaluate the knowledge and perception of knowledge regarding breast cancer risk and risk reduction measures with a specific questionnaire

  5. Subject anxiety

    Time frame: At baseline, 1 year

    Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire

  6. Subject satisfaction

    Time frame: At baseline, 1 year

    Subject satisfaction will be measured using a specific questionnaire.

  7. Levers and barriers for lifestyle modifications

    Time frame: At 1 year

    Evaluate the prevalence of predefined or self-assessed potential levers and barriers for lifestyle modifications

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • European Union

Registry information

Official study title

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

Acronym: MyPREV

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 13, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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