Life and Bladder Cancer (LABC): The Yorkshire Cancer Research Bladder Cancer Patient Reported Outcomes Survey (Cross-Sectional Evaluation) (ODR1920_114)

The Data Recipient will process linked cancer registration Live and Bladder Cancer (LABC) response data for an ethically approved research study into health related quality of life (HRQL) in bladder cancer patients from Yorkshire, Humber, South Tees and North Derbyshire. The study consists of consented cohort. Patients were recruited through hospitals in Yorkshire, South Tees and Chesterfield (Airedale, Barnsley, Bradford, Calderdale and Huddersfield, Chesterfield, Doncaster, Harrogate, Hull, Leeds, Mid Yorks, North Lincs, Rotherham, Sheffield, South Tees, York). However, they could be resident anywhere in England. This agreement seeks to extend the term of the DSA for 12 months.

This research aims to:

- Describe the health-related quality of life (HRQL) of people living with and beyond bladder cancer in Yorkshire, Humber, South Tees and North Derbyshire

- Gain a deeper understanding of the variation in outcomes

- To explore if and how HRQL is associated with or predicted by disease treatment and/or patient characteristics with a view to informing service delivery in order to better meet patient needs.

- Understand differences between newly diagnosed patients, those undergoing treatment and those having completed treatment for bladder cancer in Yorkshire and compare different treatments and healthcare providers

- Identify unmet needs.

The following pseudonymised datasets were previously disseminated by Public Health England to the University of Leeds.

NDRS Cancer Registrations

NDRS Linked HES APC

NDRS Linked HES Outpatient

NDRS National Radiotherapy Dataset (RTDS)

NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

The national data opt-out does not apply where explicit consent has been obtained from the patient for the specific purpose.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

The data was previously supplied by Public Health England (PHE) and the processing activities are below. Quality Health Ltd were involved at the start of the study but are no longer processing any survey data (and never had access to any NHS England data).

1. The NDRS had already obtained information on patients who have a diagnosis of bladder cancer (BC). This information is obtained in accordance with Section 251 of the Health and Care Act.

2. NDRS and the Study team wrote to the participating Trusts with information relating to the study along with a copy of the proposed PROM questionnaire and covering letter was sent out to survey participants. The Chief Executive and bladder cancer Multi-Disciplinary Team (MDT) lead was written to and their permission to survey people treated by their Trust was sought. Trusts were offered the chance to see the list of patients that were proposed to be surveyed. In this way Trusts were offered the chance to verify that the identified patients have had a diagnosis of BC and will have the opportunity to filter any patients where it is thought not appropriate that contact be made.

3. Once the lists had been agreed (after amendment by NDRS if required) they were sent to Quality Health Ltd (approved survey provider). Quality Health Ltd sent this list to NHS Digital, who cleaned the list, removing patients who have registered type 2 objections and deceased patients. The death checks were performed using the NHS Demographic Batch Service, operated by NHS Digital.

4. The updated list was sent to Quality Health Ltd, who obtained up-to-date addresses and prepared the survey packs for participants.

5. Quality Health Ltd contacted NHS England so that an additional death check can be performed immediately prior to sending the survey packs.

6. Quality Health Ltd sent out the survey packs. The questionnaire was sent out with a covering letter from the treating NHS Trust’s Chief Executive and BC MDT lead, a summary PIS and a full version of the PIS, so that participants have more details about the study and instructions for how to complete the questionnaire online if they would prefer. The questionnaire had a unique study identification number but contained no other identifiable information in its uncompleted form. By completing the questionnaire, the participant is consenting to take part in the study.

7. The questionnaires were returned to Quality Health Ltd either in a freepost envelope, by completing the questionnaire online or over the telephone. If people did not wish to participate, they were advised to return the blank questionnaire or contact the free survey helpline to inform them that they do not wish to complete the questionnaire.

8. The unique questionnaire identification number was linked back to the original patient list in order to keep track of which people have returned the questionnaire or have opted out (by returning the questionnaire blank or phoning the dedicated questionnaire helpline). One reminder will be sent (with additional death checks performed).

9. The questionnaire data was cleaned and anonymised by Quality Health Ltd to remove any identifying information.

10. The cleaned data was sent back to NDRS using a secure transfer mechanism. NDRS linked the questionnaire data back to the necessary patient, disease and treatment information contained within the cancer systems.

11. NDRS forwarded the dataset of pseudonymised questionnaire responses, disease and treatment information alongside a study identification number (only) to the study team in Leeds for analysis. The data will be stored within the secure environment at the Leeds Institute for Data Analytics (LIDA).

The pseudonymised data will be stored within the Leeds Analytic Secure Environment for Research (LASER), a secure Microsoft Azure cloud-based system provided by the University of Leeds. LASER meets Data Protection Toolkit (DSPT) regulations and ISO 27001 certifications.

LASER uses Microsoft Azure Backup Service to enable backup and restore of data from the Azure cloud.

The data will be accessed by members of the study analysis team at the University of Leeds via remote access, which comply with the following remote access obligations:

-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;

The Data will not be linked with any other data

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts/researchers from the University of Leeds will process/analyse the Data for the purposes described above. All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The LABC team and collaborators will continue to analyse the data from the Life and Bladder Cancer PROMs questionnaires.

Papers in progress include analysis of the longitudinal questionnaire data, decision regret and social difficulties.

Colleagues would access the LABC PROMs study dataset to explore how PROMs questionnaires could guide treatment choice.

It is anticipated that the work will be completed by 4th September 2024.

The following outputs are envisaged:

· Empirical knowledge of key clinical, socio-demographic and psychosocial factors that predict patients’ generic and cancer-specific HRQL. Findings will be disseminated through a series of reports, academic papers (open-access) and conference presentations, and all findings will be available on the dedicated study website.

· The electronic report and toolkit will be available to key stakeholders to provide detailed anonymised information. The toolkit will enable each NHS Trust, Clinical Commissioning Group and Strategic Clinical Network to visualise the results for their organisation and to compare them against the national ‘average’.

· A validated survey tool for the collection of health outcomes of BC survivors. This would be made available for use by other organisations and researchers (dependent upon appropriate conditions of use).

The results will be made available to patients, their partners/spouses/carers, the funders, NHS, social care, voluntary sector organisations and other researchers through public and professional reporting. Comparative reports of service provider performance outcomes will also be produced. Reports will be disseminated through engagement with professional and patient representative bodies.

Knowledge of PROMs for patients with a new diagnosis of BC, those undergoing treatment for BC or following treatment will deliver several potential key benefits for patient care.

Firstly, it will be understood what matters most to patients. This will allow healthcare providers to develop strategies and to invest in pathways that address these concerns. Secondly, it will identify areas of excellent practice that can be highlighted for other services to learn from and will identify areas where more resources are needed.

Thirdly, changes over time following BC treatment will be understood. This knowledge will be used to better educate new patients about treatment choices and likely expectations. Finally, a BC PROMs tool will be developed that, hopefully, could be used nationally to improve the care of all patients with BC.

The primary aims of the Life and Bladder Cancer (LABC) study are to describe the health related quality of life of patients living with bladder cancer diagnosed in Yorkshire, Humber, North Derbyshire and South Tees, to gain a deeper understanding of the variation in outcomes and to identify areas of unmet need.

LABC collected PROMs via questionnaires designed to capture the impact of cancer and its treatment on general health, quality of life and social lives. Obtaining this information directly from patients is vital to get a person-centred perspective on the consequences of bladder cancer. Also, by linking the patient reports with individuals' treatment details University of Leeds and University of Sheffield can try to understand what may lead some people to experience more problems than others.

The resulting data continues to be analysed.

The published articles and scientific papers to date include:

1) Samantha J. Mason et al. Health-related quality of life after treatment for bladder cancer in England. British Journal of Cancer, 2018 https://www.nature.com/articles/s41416-018-0084-z

2) Samantha J. Mason et al. Evaluating patient‐reported outcome measures (PROMs) for bladder cancer: a systematic review using the COnsensus‐based Standards for the selection of health Measurement Instruments (COSMIN) BJUI International, 2018 https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.14368

3) Samantha J. Mason et al. Life and Bladder Cancer: Protocol for a longitudinal and cross-sectional Patient Reported Outcomes study of Yorkshire (UK) patients, BMJ Open, 2019 https://bmjopen.bmj.com/content/9/6/e030850

4) Catto JWF et al. Quality of Life After Bladder Cancer: A Cross-sectional Survey of Patient-reported Outcomes. Eur Urol. 2021 May;79(5):621-632

5) Fight Bladder Cancer Article- The Life After Bladder Cancer Project, Fight Magazine, 2nd edition, p12-13

6) Fight Bladder Cancer Article- Understanding the impact of bladder cancer: An update on the Life and Bladder Cancer (LABC) project, Fight Magazine,13th edition, p37-39 https_fightbladdercancer.co.uk_sites_default_files_downloads_FBC_20MAGAZINE_20NUMBER_2013_20DIGITAL.pdf

7) Jubber I et al. Sexual Activity, Function and Dysfunction After a Diagnosis of Bladder Cancer J Sex Med 2022;19:1431-1441. https://www.jsm.jsexmed.org/article/S1743-6095(22)01504-1/fulltext

8) Lifestyle factors in patients with bladder cancer: A contemporary picture of tobacco smoking, electronic cigarette use, body mass index and levels of physical activity European Urology Focus ( in press)