MR1480 - Life and Bladder Cancer : The Yorkshire Cancer Research Bladder Cancer Patient Reported Outcomes Survey

The purpose of the Amendment is to add 2 further list cleans. List cleans are a service carried out by NHS Digital to provide the latest demographic details including fact of death and confirmation of address details for those patients who have not raised a type 2 objection. The application originally included 2 list cleans and the project now needs 4 in total (1 having already been sent).

To allow the study team to test the questionnaire process they have decided to split the original cohort of around 4000 bladder cancer patients and send out a pilot group of 400 questionnaires. Both questionnaire distributions require 2 list cleans (one for the original distribution and one for the reminder follow up after 3 weeks) therefore 4 list cleans in total are now required.

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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 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.

The primary aims of the Life and Bladder Cancer (LABC) study are to describe the Health Related Quality of Life (HRQL) 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.

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 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.

2. Cross-sectional survey of PROMs within patients living with and beyond bladder cancer.

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 the NHS Digital list cleaning service to remove people who have registered a type 2 objection from this cohort, 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 LABC cross-sectional survey cohort (excluding any cross-sectional cohort participants who have raised type 2 objections) for the purpose of administering a PROMs survey of people diagnosed with bladder cancer in Yorkshire, Humber, North Derbyshire and South Tees.

No NHS Digital data is being shared under this agreement for the longitudinal survey.

Cross sectional cohort

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 require access to the NHS Digital list cleaning service to:

1) Remove people who have registered a type 2 objection from this cohort. This will ensure that questionnaires are not sent out inappropriately to people who has asked not to be involved in research.

2) Provide fact of death. The list clean will remove people who have died from the cohort list. This will ensure that surveys are not sent to people who have died and avoid any potential upset to their relatives from receiving the mailing. Death checks will be carried out immediately prior to survey mail out (initial and reminder). However, it must be acknowledged that even with the most stringent checks, a small number of individuals may have died very close to the time of survey mailing and these will receive a survey.

3) 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:

• 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.

• 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 bladder cancer survivors. This would be made available for use by other organisations and researchers (dependent upon appropriate conditions of use).

Four hundred questionnaires have been sent out to bladder cancer patients as part of the cross sectional pilot send out.

The questionnaires should have reached participants in week commencing 5th November 2018.

A reminder will be list cleaned and sent out 3 weeks after the original to participants who have not responded.

To date 2 online replies have been received.

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 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.

The primary aims of the Life and Bladder Cancer (LABC) study are to describe the Health Related Quality of Life (HRQL) 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.

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 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.

2. Cross-sectional survey of PROMs within patients living with and beyond bladder cancer.

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 the NHS Digital list cleaning service to remove people who have registered a type 2 objection from this cohort, 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 LABC cross-sectional survey cohort (excluding any cross-sectional cohort participants who have raised type 2 objections) for the purpose of administering a PROMs survey of people diagnosed with bladder cancer in Yorkshire, Humber, North Derbyshire and South Tees.

No NHS Digital data is being shared under this agreement for the longitudinal survey.

Cross sectional cohort

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 require access to the NHS Digital list cleaning service to:

1) Remove people who have registered a type 2 objection from this cohort. This will ensure that questionnaires are not sent out inappropriately to people who has asked not to be involved in research.

2) Provide fact of death. The list clean will remove people who have died from the cohort list. This will ensure that surveys are not sent to people who have died and avoid any potential upset to their relatives from receiving the mailing. Death checks will be carried out immediately prior to survey mail out (initial and reminder). However, it must be acknowledged that even with the most stringent checks, a small number of individuals may have died very close to the time of survey mailing and these will receive a survey.

3) 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:

• 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.

• 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 bladder cancer survivors. This would be made available for use by other organisations and researchers (dependent upon appropriate conditions of use).

Yielded Benefits is not a requirement for new applications.