PET-CT guided, symptom-based, patient-driven surveillance versus clinical follow-up in advanced head neck cancer (PETNECK 2)

The University of Birmingham requires access to NHS England Data for the purpose of the following research project:

PET-CT guided, symptom-based, patient-initiated surveillance versus clinical follow-up in advanced head neck cancer (PET NECK 2)

The following is a summary of the aims of the research project provided by the study team on behalf of the University of Birmingham:

PETNECK 2 is an unblinded, multicentre, non-inferiority, phase III, randomised controlled trial (RCT), with an in-built pilot, a nested QuinteT Recruitment Intervention and a nested mixed methods study on patient experience and fear of recurrence in head and neck cancer (HNC). Routine clinical follow-up protocols for cancer surveillance, whilst widely accepted, lack a robust evidence-base. They may not be the most effective or cost-effective method of early cancer recurrence detection.

Whilst being the international standard, current strategies for HNC surveillance lack a robust evidence base and are inefficient. The rate of detection of a cancer recurrence using routine clinical surveillance is low – especially in asymptomatic patients. One study of 1039 consultations identified suspicion of recurrence in only 10% of routine visits. In this cohort, suspicion of cancer recurrence was reported in 0.3% of asymptomatic patients seen routinely. Yet, in those patients requesting an appointment to report a new symptom, the rate of suspicion of recurrence rose to 58%, with a negative predictive value of 99.6%. In addition, the current clinical surveillance strategy detects many recurrences at an advanced stage. In a study of 4839 patients with recurrent HNC, >60% presented at an advanced stage (stage III/IV disease). Advanced stage on recurrence was statistically significantly associated with risk of death on multivariate analysis (HR 1.24, 95%CI 1.20–1.29, p<.0001).

The aims of this study are to:

• Evaluate how effective the alternative active surveillance strategy (PET-CT-guided, patient-initiated, symptom-based follow-up) is compared to the standard follow-up care.

• Determine whether the alternative follow-up strategy provides a cost-efficient approach compared to the current standard of care.

• Determine the potential benefits of a patient-initiated follow-up model in improving patient outcomes.

The PETNECK2 team need to undertake long-term follow-up of patients for the primary outcome of this trial, specifically ‘overall survival time’ which is defined as the time from randomisation to death or censoring.

The following NHS England Data will be accessed:

• Civil Registrations of Death –necessary to capture date and cause of death.

The primary outcome measure is overall survival time. Overall survival time is defined as the interval between the date of randomisation and the date of death from any cause therefore civil registration of deaths data is integral to the primary outcome.

The level of Data will be:

Identifiable - necessary because although the data provided by NHS England will contain pseudonymised fields, University of Birmingham retain access to the corresponding identifiers. While no efforts will be made to reidentify participants, the technical capability to do so remains.

The Data will be minimised as follows:

• Limited to the study cohort of patients who consented to participate.

The University of Birmingham is the research sponsor and the Controller as the organisation responsible for ensuring the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by National Institute for Health and Care Research Programme Grants for Applied Research. The funding is specifically for the trial described.

The Trial Management Group comprises individuals and Principal Investigators from Universities and NHS Trusts across the UK, however these organisations have no involvement in the Cancer Research UK Clinical Trials Unit Data processing.

The concept of the study is supported by the various, Patient Advisory Group (PAG), Patient Management Group (PMG), Patient Steering Committee (PSC), with patient advocates as members. These have been involved in the review of the study design, participated in study discussions and helped write patient facing documents such as the patient information sheet.

The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham will transfer data to NHS England. The data will consist of identifying details (specifically NHS number, date of birth, full name and gender plus unique Trial Number) for the cohort to be linked with NHS England Data.

NHS England will provide the relevant records from the Civil Registration of Death dataset to CRCTU. The Data will contain no direct identifying data items but will contain a unique Trial Number which can be used to link the Data with other record level data already held by the Recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at The University of Birmingham.

The Data will be accessed by authorised personnel via remote, or on site, 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).

Remote processing will be from secure locations within England. The Data will not leave England at any time.

Data will only be accessed and processed by employees of the University of Birmingham who have authorisation from the study team to access the Data for the purposes described. No other organisation is permitted to access the Data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

Analysts/researchers from the University of Birmingham will analyse the Data for the purposes described above.

Definitive research findings are expected to be:

• Published in peer-reviewed medical journals and presented at appropriate medical and patient meetings. This will ensure results are disseminated to the widest possible international audiences of both oncologists, surgeons and patients.

• Disseminated via patient forums and websites such as Cancer Research UK (https://www.cancerresearchuk.org/)

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

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

• Medical journals

• Social Media – Twitter/ X

• Patient forums / workshops

• Dissemination of the study results to the research community, trial participants and the public.

• Target international meetings for presentation of results to conferences and relevant national meetings.

Members of the University of Birmingham’s PETNECK2 Trial Management Group are lay representatives and will be involved in developing lay summaries of the outcomes and helping to publicise these via charities.

The target date for production and dissemination of the outputs is within one year after receiving the final set of Data (~late 2028).

Head and neck cancer accounts for >12,000 new diagnoses per annum in the UK, and its incidence is rising rapidly. The new paradigm presented here has the potential to result in significant improvements for patients, the NHS and society. In addition, as the intervention utilises existing technology and infrastructure, and is likely to be more cost-effective than the current follow-up strategy, the benefits should be realised well within 5 years from the end of the programme.

The use of Data will ensure a complete dataset for analysis of the outcome measures and for the purposes of safety monitoring of patients allocated to the intervention arm.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy and treatment decisions for HNC patients.

Yielded Benefits is not a requirement for new applications.