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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-74
SponsorUNICANCER

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Intervention

    Behavioral

    Virual Webinar and online personalised clinical visit

Treatment groups

1,508 Participants
are divided into 1 treatment group
Group A: interventionOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Prevalence of risk reduction targets

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

Time frame
From start of the inclusion up to the end of inclusions
2

WCRF

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

Time frame
At 3 months, 1 year
3

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

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

Time frame
At baseline
4

Subject knowledge and perception of knowledge

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

Time frame
At baseline, 1 year

Other outcomes

Sponsors and contacts

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UNICANCER

Lead sponsor

European Union

Collaborator