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Completed

NCT Number: NCT04359420

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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9LT, United Kingdom

About this study

In principle, risk-stratification as a routine part of the NHS breast screening programme (NHS-BSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE (National Institute of Health and Care Excellence) approved more frequent screening and/ or chemoprevention to be realised for women who are at increased risk, but are unaware of this. The invesigators have developed BC-Predict, which is offered to women when invited to NHS-BSP and collects information on risk factors (self-reported information on family history and hormone-related factors, mammographic density and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict then produces risk feedback letters, and invites women at moderate or high risk to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Key objectives of the present research are to quantify important potential benefits and harms, and to identify the key drivers of the relative cost-effectiveness of embedding BC-Predict into NHS-BSP.

A non-randomised fully counterbalanced study design will be used, to include equal numbers of participants from five screening sites who will be offered NHS-BSP and BC-Predict. Specifically, in the initial 8-month time period, women eligible for NHS-BSP in three screening sites will be offered BC-Predict, whilst women in two screening sites are offered usual NHS-BSP. In the following 8-month time period the study sites switch their offers. In total 16000 women will be invited to BC-Predict, and compared with 16000 women offered standard NHS-BSP. Key potential benefits including uptake of BC-Predict, risk consultations, chemoprevention and additional screening will be obtained from NHS-BSP and Family History, Risk and Prevention Clinic records for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires. Health economic analyses will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHS-BSP.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

BC-Predict

Other

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 names: risk stratified screening

NHS Breast Screening Programme

Other

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

Primary outcomes

  1. Prescription of chemoprevention.

    Time frame: 6 months after screening appointment

    Frequency of women taking up initial prescription of chemoprevention drugs (anastrozole/tamoxifen/raloxifene) from Family History, Risk and Prevention Clinic

    Data will be collected on each of the following aspects of this: (a) participant agrees/disagrees in clinic to take chemoprevention, (b) chemoprevention not appropriate, (c) chemoprevention appropriate but prescription not filled, (d) chemoprevention appropriate and prescription filled.

Secondary outcomes

  1. Screening attendance at first offered screening episode

    Time frame: attendance within 6 weeks of first specific appointment offered

    Attendance at NHS Breast Screening Programme appointment

  2. Screening attendance within 180 days

    Time frame: within 180 days first appointment offered

    Attendance at NHS Breast Screening Programme appointment

  3. number of recalls

    Time frame: within 6 months of first appointment offered

    number of recalls from NHS Breast Screening programme: (a) technical recalls, (b) for assessment, (c) routine recalls

  4. Number of breast cancer diagnoses

    Time frame: within 6 months of first appointment offered

    Number of breast cancers diagnosed

  5. Uptake of consultation at Family History, Risk and Prevention clinics

    Time frame: within 6 months of first appointment offered

    Family History, Risk and Prevention clinic attendance, to discuss possibly measures to reduce breast cancer risk

  6. Enrolment for more frequent screening

    Time frame: within 6 months of first appointment offered

    Uptake of more frequent screening (e.g. yearly) from NHS Breast Screening programme

  7. State anxiety

    Time frame: at 6 months of first appointment offered, controlling for baseline values

    Measured using STAI (Spielberger State Anxiety Inventory) short form. Range 6 to 24. Higher scores indicate higher anxiety.

  8. Cancer worry

    Time frame: at 6 months of first appointment offered, controlling for baseline values

    Measured using Lerman Cancer Worry Scale. Range 6 to 24. Higher scores indicate higher cancer worry.

  9. Informed choices to attend screening or not

    Time frame: at 6 months of first appointment offered, controlling for baseline values

    Informed choices regarding screening will be estimated from attitudes to screening at baseline, knowledge and screening attendance, using a standard approach reported by Marteau, Dormandy & Michie

Other outcomes

  1. Cost consequences

    Time frame: at 6 months of first appointment offered

    cost consequences analysis to understand the short-term relative impact of the risk feedback intervention (BC-Predict) based on health status (EQ-5D5L), capability (ICECAP-A); and proportion of women starting chemoprevention.

  2. Variation in uptake of services offered examined by deciles of index of multiple deprivation (as assessed using residential postcode)

    Time frame: at 6 months of first appointment

    The investigators will examine variations in proportion of people offered services (i.e. uptake of NHS Breast Screening programme and BC-Predict), between groups defined by deciles of Indices of Multiple Deprivation (derived from residential postcode). This will assess any potential exacerbation of health inequalities brought about by BC-Predict.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • Breast Cancer Now
  • East Cheshire NHS Trust
  • East Lancashire Hospitals NHS Trust
  • Manchester University NHS Foundation Trust
  • NHS Breast Screening Programme
  • National Institute for Health Research, United Kingdom
  • Prevent Breast Cancer
  • Queen Mary University of London
  • The Christie NHS Foundation Trust
  • University of Nottingham

Registry information

Official study title

What Are the Benefits and Harms of Risk Stratified Screening as Part of the NHS Breast Screening Programme: Study Protocol for a Multi-site Non-randomised Comparison of BC-Predict Versus Usual Screening

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 24, 2020
Registry last updated
Jan 10, 2023

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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