MR1466 - Life and Bladder Cancer : The Yorkshire Cancer Research Bladder Cancer Patient Reported Outcomes Survey ( Longitudinal Study)

Bladder cancer is one of the most common human cancers. Its treatment can affect the physical, psychological and sexual function of a patient, which reduces their overall quality of life. It is important to collect information about the experiences of patients as they reflect outcomes, identify areas of care that need improvement, and how to improve this care. These patient reported outcome measures (PROMs) are important measures of healthcare delivery and identify concerns that matter most to patients. The study team will develop a questionnaire that records these measures in patients with bladder cancer during and after treatment. The study team will survey all new and existing patients within Yorkshire, North Derbyshire, South Tees and the Humber and will compare outcomes across the region, across the spectrum of disease states and treatments, and over the first 12 months since diagnosis. The study team will use this information to understand outcomes within the population, to identify gaps in care and barriers to care improvement, and to shape clinical care delivery.

Whilst the treatment of bladder cancer can affect the physical, psychological and sexual function of a patient, relatively little is known about the impact of the disease and its treatment upon the overall health related quality of life of individuals. One way of finding out about the impact of bladder cancer and its treatment on patient health related quality of life is by asking patients directly using Patient Reported Outcome Measures (PROMs). Although there have been some studies evaluating the health related quality of life of people with bladder cancer, many of these have been small scale or restricted to subsets of patients. In the main there is a dearth of large scale research examining PROMs in people living with and beyond bladder cancer. The importance of PROMs as healthcare measure is recognised, and with this is mind, the study will survey PROMs for patients with bladder cancer across Yorkshire, Humber, South Tees and North Derbyshire.

The data requested under this agreement will be used in relation to a longitudinal cohort, however the LABC project has two complementary sub studies that use different patient cohorts in different designs;

1. Longitudinal survey of PROMs within the first year of diagnosis requires informed consent to be taken from participants. The study requires access to the NHS Digital list cleaning service to provide fact of death.

2. Cross sectional survey of PROMs within patients living with and beyond bladder cancer (for information only- this part of the study is covered by a separate Data Sharing Agreement).

All patients alive within 10 years of a current or previous diagnosis of bladder cancer having been treated by one of the NHS hospitals in Yorkshire, Humber, South Tees and North Derbyshire will be invited to complete a single survey unless they have registered a type 2 objection. Patients with all types and stages of bladder cancer will be included. The study requires access to check the most current address and to provide fact of death.

The NHS Digital list cleaning service will be used to carry out mortality checks and retrieve current patient addresses for those people in the Life and Bladder Cancer (LABC) survey cohort for the purpose of administering a Patient Reported Outcome Measures (PROMs) survey of people diagnosed with bladder cancer in Yorkshire, Humber, North Derbyshire and South Tees.

There are a number of organisations involved in the LABC study, and their involvement is detailed below. However, data provided by NHS Digital will be received and processed only by Quality Health Ltd.

Quality Health Ltd

Quality Health is a Care Quality Commission (CQC) approved national contractor and works for 360 NHS Trusts throughout England on the National Patient and Staff Surveys. Quality Health are the LABC study data processor. They will send and receive the questionnaires, storing the survey mailing and response data on their systems. Quality Health will destroy identifying data needed for mailing when the surveys have closed and the questionnaire information that is retained will only be identified by a unique identification number. The returned completed questionnaires will be stored in paper and electronic formats within the secure systems used routinely by Quality Health Ltd. The electronic version of the survey data will be encrypted and sent securely to the National Cancer Registration and Analysis Service.

National Cancer Registration and Analysis Service (NCRAS), Public Health England (PHE):

NCRAS is run by Public Health England and is responsible for cancer registration. PHE will store patient details received from the recruiting hospitals and send the collated patient details to Quality Health Ltd.

University of Sheffield:

Joint study research location and sponsor of the LABC study. The CI and the Project Coordinator are based at the University of Sheffield. No patient identifiable data will be held at the University of Sheffield.

University of Leeds and Leeds Institute for Data Analytics (LIDA):

Joint study research location. The CI and the PROMs design and statistical team members are based at the University of Leeds. The Leeds research team are also part of the Leeds Institute for Data Analytics (LIDA) The linked survey response data will be analysed by the study team at Leeds University (in pseudonymised format only). The cleaned and pseudonymised data will be sent to the University of Leeds using a secure transfer mechanism (Leeds Institute for Data Analytics (LIDA) web drop system) and stored securely on the LIDA integrated research campus (IRC) platform.

Study Methodology Summary:

Participants who have given informed consent to take part in the study may provide information by completing the survey either via post, telephone or online. The survey will not ask for personal details such as names and addresses and each survey will include a unique study ID number. Participants will complete their survey online, by telephone or return it in the post to an NHS approved survey company, Quality Health Ltd, (the data processor). Quality Health Ltd will remove any personal information that may directly identify participants. This data will then be sent to the University of Leeds for analysis.

Quality Health require NHS Digital to perform a list-cleaning service and to provide the latest demographic details including fact of death and, for living participants who elected to receive surveys by post, confirmation of address details.

Access to the data is limited to Quality Health Ltd and will only be used for the purpose of this Agreement.

Quality Health will submit a data file to NHS Digital containing the following limited patient identifying data fields for patients in the LABC PROMs cohort:

- Name

- Surname

- Address

- Postcode

- NHS number

- Date of birth

- Gender

For each individual who elected to complete the survey by telephone or by email, the data file will include an indicator so that latest address details will not be supplied for these individuals.

NHS Digital will supply the output from the list-cleaning service to Quality Health.

The administration of the questionnaire (following the list cleaning) will be carried out by Quality Health who will act as a central data collection centre. NCRAS at Public Health England will transfer minimal patient identifiable information including names and addresses, post code, date of birth, NHS number, gender and a unique LABC identifier to Quality Health. Quality Health will pass these details on to NHS Digital for list cleaning as described above.

Following receipt of the completed questionnaires, Quality Health will clean and pseudonymise the data to remove any identifying information. The cleaned data is sent back 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).

Data from NHS Digital is only provided to Quality Health Ltd, and only for the purpose of administering the surveys.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data)

The objective of the longitudinal arm of the study will be to evaluate changes in PROMs in patients with bladder cancer over time. All new incident cases within a 12-month period (est. n=1900) at 3,6,9 and 12 months post- diagnosis will be studied. Participants will give informed consent.

The study requires use of the NHS Digital list-cleaning service to:

1) Provide fact of death. The list clean will remove people who have died from the cohort list. This will minimise the risk of surveys being sent to people who have died potentially causing upset to their relatives. Death checks will be carried out immediately prior to survey mail out (initial and two reminders).

2) To check the most current address for mailing the survey. By providing up-to-date addresses NHS Digital will help the study work towards achieving the highest possible response rate and therefore make the results more representative of the population.

The following outputs from the study are envisaged:

1) Empirical knowledge of key clinical, socio-demographic and psychosocial factors that predict patients generic and cancer- specific Health Related Quality of Life (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.

2) 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'

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

None of the above outputs from the study will contain data from NHS Digital.

The list cleaning with NHS Digital data has 2 key benefits:

1) Latest addresses are obtained so that follow-up has greater coverage, and

2) As far as possible, surveys are not sent out to addresses of patients who are deceased, which could cause distress.

Whilst the treatment of bladder cancer can affect the physical, psychological and sexual function of a patient, relatively little is known about the impact of the disease and its treatment upon the overall health related quality of life of individuals.

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.

Yielded Benefits is not a requirement for new applications.