CompletedNot Applicable

What Are the Benefits and Harms of Risk Stratified Screening in the NHS Breast Screening Programme: Study Protocol

United Kingdom32,298 participantsStarted 2019-08-01

Plain-language summary

This study aims to identify key benefits and harms of integrating risk stratification (the BC-Predict intervention) into the NHS Breast Screening Programme. A non-randomised fully counterbalanced study design will be used, whereby women from screening sites will be offered usual NHS Breast Screening Programme or BC-Predict for an eight month period, followed by a cross-over point where women at each site will be offered the other invention during an eight month period.

Who can participate

SexFEMALE

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Inclusion Criteria: * born biologically female, * invited for either (a) first breast screening appointment (any age) or: (b) aged 57-63 years (only at East Cheshire and East Lancashire breast screening programmes), * able to provide informed consent and complete a risk assessment questionnaire. Exclusion Criteria: * previously has had breast cancer, * has had bilateral mastectomy, or * has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study

What they're measuring

Prescription of chemoprevention.

Timeframe: 6 months after screening appointment

Trial details

NCT IDNCT04359420

SponsorUniversity of Manchester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-28

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