What clinical outcomes are associated with the 'joint care' proposed by NHS England for Teenagers and Young Adults with cancer (BRIGHTLIGHT-2021)

University College London Hospitals NHS Foundation Trust (UCLH) requires access to NHS England data for the purpose of the following research project:

What clinical outcomes are associated with the 'joint care' proposed by NHS England for Teenagers and Young Adults with cancer (BRIGHTLIGHT-2021)

The following is a summary of the aims of the research project provided by UCLH:

England has 13 specialist Teenage and Young Adult Principal Treatment Centres (TYA-PTC) designed to treat not only the rare cancers occurring in young people but also to support their unique psychosocial needs. The TYA-PTC operate within networks linked to designated hospitals (DH) which can deliver some or all aspects of specialist TYA care. Healthcare policy states that those aged 18 or under must have care delivered within the PTC and those aged 19-24 years can choose whether to have their care in the TYA-PTC or delivered more locally to home in the DH. This model of care was rolled out without formal evaluation of the outcomes associated with care delivered by the TYA-PTC. Not all young people have care delivered by the TYA-PTC (even those under 18 years). This results in three natural groups of patients: those with all their care in the TYA-PTC (all-TYA-PTC), those with no care in the TYA-PTC (no-TYA-PTC) and those with some care in the TYA-PTC. UCLH’s previous study BRIGHTLIGHT was the first systematic evaluation of TYA cancer services in England.

BRIGHTLIGHT included a cohort study examining differences in quality of life (QoL), survival and costs of specialist care based on the level of exposure to the Teenage and Young Adult Principal Treatment Centres (TYA-PTC) (all, some, or none). A difference was observed but not as expected. Results suggested place of care mattered considerably and TYA in the some-TYA-PTC experienced inferior QoL and lower survival compared to the all-TYA-PTC and no-TYA-PTC groups. These findings indicate that care split between TYA-PTCs and other trusts may produce inferior outcomes. This is concerning as the new TYA service specification promotes enhanced care for the some-TYA-PTC group, newly termed ‘joint care’, delivered by the TYA-PTC and other NHS Trusts together. The BRIGHTLIGHT study was conducted when the establishment of many TYA-PTC was still embryonic, and we proposed that since then (2012) the culture of TYA care, and links between the TYA-PTCs and DHs, have become more established. BRIGHTLIGHT_2021 was a rapid re-evaluation of the nature, drivers and barriers to quality for care that is in one place or is split in its delivery between a TYA-PTC and another centre, and the key TYA patient outcomes associated with varying degrees of exposure to specialist care. BRIGHTLIGHT_2021 aims to inform healthcare policy for TYA to maximise outcomes for this group.

Specifically, the aims and objectives of BRIGHTLIGHT_2021 are to:

i. Determine if clinically significant differences exist in outcomes for TYA receiving joint care compared to all or no-TYA-PTC care in 2021.

ii. Explore the processes used to enable inter-organisational collaboration under joint care models.

iii. Determine the outcomes associated with joint care and how they may be optimised.

This will allow for the organisation of TYA services in a way to maximise both clinical and psychosocial outcomes for young people with cancer allowing them to return to as healthy a life as possible following their cancer diagnosis and treatment.

The following NHS England Data will be accessed:

• Cancer Registration – necessary because the “Date of Diagnosis” fields in this dataset is required in order to calculate survival time for each participant in the study.

The level of the Data will be:

• Identifiable

The data shared with UCLH by NHS England is pseudonymised, however IQVIA will share confidential patient information with UCLH therefore the data held by UCLH will be identifiable.

The Data will be minimised as follows:

• Limited to a study cohort identified by UCLH– This cohort consists of 248 people diagnosed with cancer, who are aged between 16-24 years old, who were enrolled in the BRIGHTLIGHT_2021 Study between 1st March 2022 and 31st December 2022.

University College London Hospitals NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that 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 meets the public interest because young people currently have the poorest outcomes in comparison to children and older adults, yet their potential worth to society is huge in terms of becoming a useful citizen. Providing specialist services that deliver high quality cancer care but in addition, support returning to work and education, providing peer support and psychological care has been implemented to mitigate the outcome differences. The current service specification recommends ‘joint care’ between the specialist TYA Principal Treatment Centre and designated hospitals. However, our previous BRIGHTLIGHT study showed that these patients had inferior outcomes and higher NHS and patient costs compared to those who had all their care in one setting. BRIGHTLIGHT_2021 aims to quantify if TYA services have evolved and care being delivered as Joint care is as good as those have all their care in one setting.

The funding is provided by the National Institute of Health and Care

Research (NIHR). The funding is specifically for the study described. Funding is in place until April 2025.

The funder will have no ability to suppress or otherwise limit the publication of findings.

University College London (UCL) is a processor acting under the instructions of UCLH. UCL’s role is limited to undertaking the data analysis, through a researcher substantively employed by UCL.

Each of the following organisations are involved in the study, but they will not be accessing, or determining the means of processing NHS England data:

1. University of Leeds

2. University of Manchester

3. Teenage Cancer Trust

4. Managed Service Network for Children & Young People with Cancer for Scotland

The following organisations were involved in identifying participants, but they will not be accessing, or determining the means of processing NHS England data:

1. Clatterbridge Cancer Centre NHS Foundation Trust

2. The Newcastle Upon Tyne Hospitals NHS Foundation Trust

3. Nottingham University Hospitals NHS Trust and University Hospitals of Leicester NHS Trust

4. University Hospital Southampton NHS Foundation Trust

5. The Royal Marsden NHS Foundation Trust

6. University Hospitals Bristol NHS Foundation Trust

7. University Hospital Birmingham NHS Foundation Trust

8. Leeds Teaching Hospitals NHS Trust

9. Sheffield Teaching Hospital NHS Foundation Trust

10. Cambridge University Hospitals NHS Foundation Trust

11. Oxford University Hospitals NHS Foundation Trust

12. The Christie NHS Foundation Trust

13. University College London Hospitals

14. University Hospital of Wales

15. West of Scotland Cancer Centre

IQVIA will be submitting the patient identifiable details for the cohort to NHS England. IQVIA are a classified as a commercial organisation. Although they may not gain a commercial benefit as a result of this study, they may gain a reputational benefit due to the service that they are providing.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group strongly supported the collection of the data for the purposes described above. The young advisory panel (YAP) have contributed to the study design, management, recruitment/retention interventions and dissemination of outputs. Two of the YAP members, who have been involved since the start of the original BRIGHTLIGHT study, joined the research team and they will reach out to a wider group of young people supported by the PPI lead.

IQVIA will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the Cancer Registration dataset to University College London Hospitals NHS Foundation Trust (UCLH). The Data will

• contain no direct identifying data items but will contain a unique person ID 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 UCLH

The Data will be accessed onsite at the premises of UCLH.

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.

- 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.

Access is restricted to employees of UCLH and UCL who have authorisation from the Chief Investigators.

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

The Data will be linked at person record level with to the pseudonymised data patient reported data set. The outputs will not identify at individual patient, primary care provider, or hospital level, the outputs will identify specialist TYA services as a whole.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Analysts from the UCLH and UCL will process the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to the funder (NIHR). UCLH are required to provide a report to the NIHR by April 2025 and end of study report to National Research Ethics Service the date of this will depend on the release of the data requested in this application/a report will also be prepared for the NIHR medical journal library, Q3 2025.

• Submissions to peer reviewed journals, anticipated journals include British Medical Journal Open.

• Presentations at the Global Adolescent and Young Adult Congress in Melbourne, December 2024 (output already realised). Also, results presented to other national conferences by poster or oral presentation planned throughout 2025 and early 2026.

• A database to be utilised as a resource for health research

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 dataset from which the information was derived.

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

• Journals

• Workshops involving the Young Advisory Panel (YAP): UCLH will host a workshop (online or face to face) to disseminate the study results to our YAP. This is a Group of young people who have worked with us throughout BRIGHTLIGHT and BRIGHTLIGHT_2021. They have contributed to study design, survey content, supported interventions to boost survey returns and contributed to interpretation of results in the original BRIGHTLIGHT study. Also, UCLH plan to hold a one-day stakeholder workshop to discuss the results, gaps in evidence and how BRIGHTLIGHT_2021 can inform future policy to maximise outcomes for TYA.

• Policy maker dissemination: BRIGHTLIGHT will present the results to the Children’s and Young Peoples, Clinical Reference Group (CRG) who are responsible for the design and policy recommendations for TYA. BRIGHTLIGHT will invite the CRG to author an editorial alongside the publication in the British Medical Journal Open.

• Social media

• Study Website – Accessible results will be shared on the BRIGHTLIGHT study website (www.brightlightstudy.com)

• Public events - Teenage Cancer Trust host national days for the TYA lead nurses across the UK, many of whom were Principal Investigators. BRIGHTLIGHT have been invited to present the study results at one of their days, date waiting confirmation.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

The future service specification will be informed by the BRIGHTLIGHT_2021 study. Allowing services to be designed in such a way that it maximises outcomes for young people with cancer.

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 decisions for or within the NHS or treatment decisions in relation to specific patients.

BRIGHTLIGHT have close links with relevant charities who provide services for young people with cancer. A doctor from Teenage Cancer Trust is a Co-Applicant on the Grant. BRIGHTLIGHT are hosting a multi stake holder workshop in April 2025 which has attendees from Young Lives with Cancer. BRIGHTLIGHT also have a patient Group who have links into other patient forums to promote the study results.

Not stated in the register.