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

Conditions

Breast Cancer

Keywords

breast cancer, Screening, risk stratification, high risk, psychological impact, early detection, mammographic density, chemoprevention, Tyrer-Cuzick, anxiety

Brief 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.

Detailed 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.

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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 (NCT04359420)

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Interventions

OTHERBC-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

OTHERNHS Breast Screening Programme

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

A non-randomised fully counterbalanced study design will be used, to include equal numbers of participants from all sites who will be offered NHS-BSP and BC-Predict. Specifically, in the initial 8-month time period, women eligible for breast screening 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 to offer the other intervention (NHS-BSP rather than BC-Predict; and vice versa). This will allow estimates of effect to be obtained from both within-sample and between-sample analyses.

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Prescription of chemoprevention.	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

Measure	Time frame	Description
Screening attendance at first offered screening episode	attendance within 6 weeks of first specific appointment offered	Attendance at NHS Breast Screening Programme appointment
Screening attendance within 180 days	within 180 days first appointment offered	Attendance at NHS Breast Screening Programme appointment
number of recalls	within 6 months of first appointment offered	number of recalls from NHS Breast Screening programme: (a) technical recalls, (b) for assessment, (c) routine recalls
Number of breast cancer diagnoses	within 6 months of first appointment offered	Number of breast cancers diagnosed
Uptake of consultation at Family History, Risk and Prevention clinics	within 6 months of first appointment offered	Family History, Risk and Prevention clinic attendance, to discuss possibly measures to reduce breast cancer risk
Cancer worry	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.
Informed choices to attend screening or not	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
Enrolment for more frequent screening	within 6 months of first appointment offered	Uptake of more frequent screening (e.g. yearly) from NHS Breast Screening programme
State anxiety	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.

Other

Measure	Time frame	Description
Cost consequences	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.
Variation in uptake of services offered examined by deciles of index of multiple deprivation (as assessed using residential postcode)	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.

Countries

United Kingdom

Outcome results

None listed