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

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.

Conditions

• Breast Cancer

Interventions

OTHER

BC-Predict

BC-Predict is an automated system for offering an assessment of breast cancer risk to women when they receive their NHS Breast Screening Programme invitation, and generating letters to feedback this risk to women and relevant healthcare professionals. Women at higher risk are offered chemoprevention drugs and additional mammography

OTHER

NHS Breast Screening Programme

usual care from NHS Breast Screening Programme, consisting of mammography every three years for most women.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Breast Cancer Now

  collaborator OTHER

• Prevent Breast Cancer

  collaborator UNKNOWN

• Queen Mary University of London

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• East Lancashire Hospitals NHS Trust

  collaborator OTHER

• East Cheshire NHS Trust

  collaborator UNKNOWN

• NHS Breast Screening Programme

  collaborator UNKNOWN

• The Christie NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  lead OTHER

Principal Investigators

• Gareth Evans, MD · Manchester University NHS Foundation Trust

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2021-12-28

Completion

2022-06-30

Countries

• United Kingdom

Study Locations