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

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359420
• Other study ID #: RP-PG-1214-20016
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32298
• Est. completion date: June 30, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Manchester University NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (11)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost consequences	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.	at 6 months of first appointment offered
Other	Variation in uptake of services offered examined by deciles of index of multiple deprivation (as assessed using residential postcode)	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.	at 6 months of first appointment
Primary	Prescription of chemoprevention.	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.	6 months after screening appointment
Secondary	Screening attendance at first offered screening episode	Attendance at NHS Breast Screening Programme appointment	attendance within 6 weeks of first specific appointment offered
Secondary	Screening attendance within 180 days	Attendance at NHS Breast Screening Programme appointment	within 180 days first appointment offered
Secondary	number of recalls	number of recalls from NHS Breast Screening programme: (a) technical recalls, (b) for assessment, (c) routine recalls	within 6 months of first appointment offered
Secondary	Number of breast cancer diagnoses	Number of breast cancers diagnosed	within 6 months of first appointment offered
Secondary	Uptake of consultation at Family History, Risk and Prevention clinics	Family History, Risk and Prevention clinic attendance, to discuss possibly measures to reduce breast cancer risk	within 6 months of first appointment offered
Secondary	Enrolment for more frequent screening	Uptake of more frequent screening (e.g. yearly) from NHS Breast Screening programme	within 6 months of first appointment offered
Secondary	State anxiety	Measured using STAI (Spielberger State Anxiety Inventory) short form. Range 6 to 24. Higher scores indicate higher anxiety.	at 6 months of first appointment offered, controlling for baseline values
Secondary	Cancer worry	Measured using Lerman Cancer Worry Scale. Range 6 to 24. Higher scores indicate higher cancer worry.	at 6 months of first appointment offered, controlling for baseline values
Secondary	Informed choices to attend screening or not	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	at 6 months of first appointment offered, controlling for baseline values