Breast CancerNCT04359420
What Are the Benefits and Harms of Risk Stratified Screening in the NHS Breast Screening Programme: Study Protocol
A study testing BC-Predict and NHS Breast Screening Programme in people with Breast Cancer, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BC-Predict and NHS Breast Screening Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,298 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- previously has had breast cancer,
- has had bilateral mastectomy, or
- has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- BC-Predict, NHS Breast Screening Programme
- Keywords
- breast cancer, Screening, risk stratification, high risk, psychological impact, early detection, mammographic density, chemoprevention, Tyrer-Cuzick, anxiety
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BC-PredictOther
Also called risk stratified screening
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 ProgrammeOther
usual care from NHS Breast Screening Programme, consisting of mammography every three years for most women.
| Study group | Role | What they receive |
|---|---|---|
| BC-Predict | Experimental | 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. Receives: Other: BC-Predict |
| NHS-Breast Screening Programme | Active comparator | Usual care in the NHS Breast Screening Programme, which involves mammography every 3 years for the majority of women Receives: Other: NHS Breast Screening Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after screening appointment
Secondary outcomes (9)
Screening attendance at first offered screening episode
Attendance at NHS Breast Screening Programme appointment
Measured: attendance within 6 weeks of first specific appointment offered
Screening attendance within 180 days
Attendance at NHS Breast Screening Programme appointment
Measured: within 180 days first appointment offered
number of recalls
number of recalls from NHS Breast Screening programme: (a) technical recalls, (b) for assessment, (c) routine recalls
Measured: within 6 months of first appointment offered
Number of breast cancer diagnoses
Number of breast cancers diagnosed
Measured: within 6 months of first appointment offered
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
Measured: within 6 months of first appointment offered
Enrolment for more frequent screening
Uptake of more frequent screening (e.g. yearly) from NHS Breast Screening programme
Measured: within 6 months of first appointment offered
State anxiety
Measured using STAI (Spielberger State Anxiety Inventory) short form. Range 6 to 24. Higher scores indicate higher anxiety.
Measured: at 6 months of first appointment offered, controlling for baseline values
Cancer worry
Measured using Lerman Cancer Worry Scale. Range 6 to 24. Higher scores indicate higher cancer worry.
Measured: at 6 months of first appointment offered, controlling for baseline values
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
Measured: at 6 months of first appointment offered, controlling for baseline values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Aug 2019
- Primary completion28 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 32,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Breast Cancer Now, Prevent Breast Cancer, Queen Mary University of London, University of Nottingham, Manchester University NHS Foundation Trust, East Lancashire Hospitals NHS Trust, East Cheshire NHS Trust, NHS Breast Screening Programme, The Christie NHS Foundation Trust
- Responsible party
- Principal investigator, David French, University of Manchester
- Investigators
- Gareth Evans, MD, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359420
- Sponsor's protocol ID
- RP-PG-1214-20016
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared in anonymised format with bone fide researchers, once main outcomes from the study have been published.
Publications
Gareth Evans D, McWilliams L, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Jerrison A, Machin M, Maxwell AJ, Howell SJ, Wright SJ, Payne K, Qureshi N, Ruane H, Southworth J, Fox L, Bowers S, Hutchinson G, Thorpe E, Ulph F, Woof V, Howell A, French DP. Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420). Br J Cancer. 2023 Jun;128(11):2063-2071. doi: 10.1038/s41416-023-02250-w. Epub 2023 Apr 1.
PubMed 37005486Pegington M, Harvie M, Harkness EF, Brentnall A, Malcomson L, Southworth J, Fox J, Howell A, Cuzick J, Evans DG. Obesity at age 20 and weight gain during adulthood increase risk of total and premature all-cause mortality: findings from women attending breast screening in Manchester. BMC Womens Health. 2023 Jan 13;23(1):17. doi: 10.1186/s12905-023-02162-0.
PubMed 36635680French DP, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Howell A, Jerrison A, Machin M, Maxwell AJ, McWilliams L, Payne K, Qureshi N, Ruane H, Sampson S, Stavrinos P, Thorpe E, Ulph F, van Staa T, Woof V, Evans DG. 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). BMC Cancer. 2020 Jun 18;20(1):570. doi: 10.1186/s12885-020-07054-2.
PubMed 32552763
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04359420
- Acronym / sponsor ID
- RP-PG-1214-20016
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Screening, risk stratification, high risk, psychological impact, early detection, mammographic density, chemoprevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,298 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Breast Cancer Now, Prevent Breast Cancer, Queen Mary University of London, University of Nottingham, Manchester University NHS Foundation Trust, East Lancashire Hospitals NHS Trust, East Cheshire NHS Trust, NHS Breast Screening Programme, The Christie NHS Foundation Trust
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BC-Predict | Experimental | Other: BC-PredictWomen 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. |
| NHS-Breast Screening Programme | Active comparator | Other: NHS Breast Screening ProgrammeUsual care in the NHS Breast Screening Programme, which involves mammography every 3 years for the majority of women |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- previously has had breast cancer,
- has had bilateral mastectomy, or
- has previously participated in the related PROCAS (Predicting Risk Of Cancer At Screening) study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BC-PredictAlso: risk stratified screeningBC-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 | BC-Predict |
| NHS Breast Screening Programmeusual care from NHS Breast Screening Programme, consisting of mammography every three years for most women. | Other | NHS-Breast Screening Programme |
Primary outcome
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.
9 secondary outcomes
Screening attendance at first offered screening episode
Time frame: attendance within 6 weeks of first specific appointment offered
Screening attendance within 180 days
Time frame: within 180 days first appointment offered
number of recalls
Time frame: within 6 months of first appointment offered
Number of breast cancer diagnoses
Time frame: within 6 months of first appointment offered
Uptake of consultation at Family History, Risk and Prevention clinics
Time frame: within 6 months of first appointment offered
Enrolment for more frequent screening
Time frame: within 6 months of first appointment offered
State anxiety
Time frame: at 6 months of first appointment offered, controlling for baseline values
Cancer worry
Time frame: at 6 months of first appointment offered, controlling for baseline values
Informed choices to attend screening or not
Time frame: at 6 months of first appointment offered, controlling for baseline values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 37005486Gareth Evans D, McWilliams L, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Jerrison A, Machin M, Maxwell AJ, Howell SJ, Wright SJ, Payne K, Qureshi N, Ruane H, Southworth J, Fox L, Bowers S, Hutchinson G, Thorpe E, Ulph F, Woof V, Howell A, French DP. Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420). Br J Cancer. 2023 Jun;128(11):2063-2071. doi: 10.1038/s41416-023-02250-w. Epub 2023 Apr 1.
- Derived from this study: PubMed 36635680Pegington M, Harvie M, Harkness EF, Brentnall A, Malcomson L, Southworth J, Fox J, Howell A, Cuzick J, Evans DG. Obesity at age 20 and weight gain during adulthood increase risk of total and premature all-cause mortality: findings from women attending breast screening in Manchester. BMC Womens Health. 2023 Jan 13;23(1):17. doi: 10.1186/s12905-023-02162-0.
- Derived from this study: PubMed 32552763French DP, Astley S, Brentnall AR, Cuzick J, Dobrashian R, Duffy SW, Gorman LS, Harkness EF, Harrison F, Harvie M, Howell A, Jerrison A, Machin M, Maxwell AJ, McWilliams L, Payne K, Qureshi N, Ruane H, Sampson S, Stavrinos P, Thorpe E, Ulph F, van Staa T, Woof V, Evans DG. 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). BMC Cancer. 2020 Jun 18;20(1):570. doi: 10.1186/s12885-020-07054-2.
- Individual participant dataSharing planned: No. Data will be shared in anonymised format with bone fide researchers, once main outcomes from the study have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Evans, MD principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BC-Predict and NHS Breast Screening Programme in people with Breast Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription of chemoprevention. (time frame: 6 months after screening appointment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04359420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.