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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07120087
• Lead Sponsor: UNICANCER

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.

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Study Start: 2025-10-01
• Primary Completion: 2026-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1508

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptance	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 Outcome Measures

Name	Time	Method
Prevalence of risk reduction targets	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
WCRF	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
Strate-Trait Anxiety Inventory - State (STAI-S)	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
Subject knowledge and perception of knowledge	At baseline, 1 year	Evaluate the knowledge and perception of knowledge regarding breast cancer risk and risk reduction measures with a specific questionnaire
Subject anxiety	At baseline, 1 year	Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire
Subject satisfaction	At baseline, 1 year	Subject satisfaction will be measured using a specific questionnaire.
Levers and barriers for lifestyle modifications	At 1 year	Evaluate the prevalence of predefined or self-assessed potential levers and barriers for lifestyle modifications

Trial Locations

Locations (2)

Gustave Roussy; 🇫🇷 Villejuif, France

AOU Città della Salute e della Scienza - CPO PiedmontSSD Epidemiologia e Screening; 🇮🇹 Torino, Italy