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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32,298
- 试验地点
- 1
- 主要终点
- Prescription of chemoprevention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •previously has had breast cancer,
- •has had bilateral mastectomy, or
- •has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study
研究组 & 干预措施
BC-Predict
Women will be sent an invitation letter one to two days after their breast screening invitation letter, directing prospective participants to the online risk assessment platform. Once participants have consented to the study online, they will be directed to the BC-Predict risk assessment questionnaire. Assessment of the online questionnaire during the pilot phase estimated that most women would be able to complete this within 30 minutes.
Women who complete the questionnaire will receive 10-year breast cancer risk estimates once they have screened negative for breast cancer, based on the Tyrer-Cuzick model, incorporating mammographic density, and for some women, SNPs (single nucleotide polymorphisms). Women who are identified as being at "high" (>8%) or "moderate" (5% and <8%) 10-year risk will be offered a consultation to discuss prevention options including prescription of chemoprevention drugs and/ or more frequent mammography as part of the NHS Breast Screening Programme.
干预措施: BC-Predict (Other)
NHS-Breast Screening Programme
Usual care in the NHS Breast Screening Programme, which involves mammography every 3 years for the majority of women
干预措施: NHS Breast Screening Programme (Other)
结局指标
主要结局
Prescription of chemoprevention.
时间窗: 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.
次要结局
- Screening attendance within 180 days(within 180 days first appointment offered)
- Screening attendance at first offered screening episode(attendance within 6 weeks of first specific appointment offered)
- number of recalls(within 6 months of first appointment offered)
- Number of breast cancer diagnoses(within 6 months of first appointment offered)
- Uptake of consultation at Family History, Risk and Prevention clinics(within 6 months of first appointment offered)
- State anxiety(at 6 months of first appointment offered, controlling for baseline values)
- Enrolment for more frequent screening(within 6 months of first appointment offered)
- Cancer worry(at 6 months of first appointment offered, controlling for baseline values)
- Informed choices to attend screening or not(at 6 months of first appointment offered, controlling for baseline values)
研究者
David French
Prof David French
University of Manchester