BENE-FIT Trial: Improving Bowel Cancer Screening Uptake

The Data will be used for the purpose of: BENE-FIT Trial: Increasing Bowel Cancer Screening Uptake (Testing the effectiveness of two behaviour change interventions).

Bowel cancer screening uptake remains relatively low in England, with particularly poor participation in minority ethnic groups and people living in more deprived areas. The BENE FIT trial is testing whether adding simple, low-cost behaviour change materials to the routine NHS bowel screening invitation process can increase the proportion of people who complete and return the FIT home test kit (and whether it can do so in the groups where uptake is currently lowest).

Objectives:

• To adapt an existing motivation + implementation intention (planning) intervention for use with the FIT kit.

• To test, in a randomised controlled trial, the effectiveness of:

o Motivation/implementation intervention

o Suggested deadline for returning the kit

o Combined intervention (motivation/implementation + suggested deadline)

o Usual care control

• To evaluate whether these interventions could support improved delivery of the NHS Bowel Cancer Screening Programme (via the NHS North East Hub, with potential for national roll-out if successful).

The Data will be used to answer the following questions:

• Does either intervention increase FIT kit return (uptake) by 6 months compared with usual care?

o Motivation/implementation intervention vs control

o Suggested deadline vs control

• Is the combined intervention more effective than either intervention alone?

o i.e., is there an interaction/synergy between motivation/implementation and suggested deadline?

• Do the interventions change how quickly people return kits?

o Using date of kit mailout and date of kit return (time-to-return/latency).

• Do the interventions work better (or worse) for particular groups?

o Differences in effects by age, gender, deprivation (IMD), ethnic mix (NOMIS/LSOA-based), and screening history (previous episodes/adequate participation).

• Do the interventions affect progression through the screening pathway among those who return kits?

o Number testing positive, colonoscopy uptake if offered, and cancers detected by 6 months.

• Are the interventions cost-effective / good value for money?

o Using observed changes in uptake plus intervention delivery costs to populate the ROI economic model.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NHS England Bowel Cancer Screening Programme Data - datasets to University of Leeds. The Data will contain no direct identifying data items. The Data will be pseudonymised, and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

Data will be stored on servers onsite at the University of Leeds

The Data will be accessed onsite at the premises of University of Leeds.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

• Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA.

• Access controls granting users the minimum level of access required are in place.

• Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data.

• Multifactor authentication (MFA) is required for remote access.

• Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access.

• All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not be linked with any other data outside of this agreement.

The expected outputs will be:

• Submission to peer reviewed journals within 9 months of trial completion

• Presentations at UKSBM Conference and other appropriate conferences

• Presentation (and report) at meeting(s) with representatives from the National Screening Committee, Screening Hubs, and relevant colleagues at NHS England, within 9 months of trial completion.

• The outputs will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Social media

• Press/media engagement

• Reports aimed at patients

• Report aimed at funder (CRUK) and distributed via their networks

• Report aimed at NHS BCSP

The BENE-FIT trial is expected to generate robust evidence on whether low-cost, scalable behaviour change materials (a motivation/implementation planning tool and/or a suggested deadline) can increase return of bowel screening FIT kits when delivered through routine NHS invitation processes. If effective, the interventions could support improved screening uptake overall, reduce inequalities in participation, and inform future service delivery and commissioning decisions.

Improved screening uptake: Increased FIT kit return (primary outcome) and potentially quicker kit return, helping more eligible people complete screening.

Reduced inequalities: Improved participation in groups with historically lower uptake (e.g., people living in more deprived areas and areas with higher minority ethnic mix), supporting a fairer screening programme.

Earlier detection and improved outcomes: By increasing participation, more positive tests and subsequent follow-up (e.g., colonoscopy where indicated) may occur, with potential for earlier cancer detection.

Service improvement and scalability: Practical evidence for a simple intervention that can be integrated into existing screening workflows and, if successful, could be rolled out more widely (including nationally).

Economic value: Cost and cost-effectiveness estimates (via a return-on-investment model) to inform decisions about whether the intervention offers value for money for the NHS.

Yielded Benefits is not a requirement for new applications.