BlAck and Mixed men’s Lived experience with prostate cANCEr – Diversity in Prostate cancer PROMs Study, also known as The BALANCE Study

Prostate cancer is the second most common cancer in men around the world. For reasons we do not fully understand, it is more likely to affect men of Black African or Black Caribbean ancestry.

These men are twice as likely to develop prostate cancer compared to White men and are more likely to be diagnosed at a younger age with more aggressive forms of the disease. 

This study focuses on better understanding how prostate cancer impacts Black men of African and Caribbean ancestry, as well as men of Mixed Black ethnic backgrounds as these groups are often underrepresented in prostate cancer research. 

For men of Mixed Black ethnic ancestry, the study also wants to explore how their mixed heritage might affect their prostate cancer risk and outcomes – an area that has not been studied enough in the past.

This study aims to make sure that voices of these groups of men are heard, their experiences are better understood and views reflected in healthcare services, policies and research. 

By completing this questionnaire, you are helping us understand how prostate cancer affects patients, namely Black men and those of Mixed Black ancestry, and find out more about their awareness about prostate cancer, access to health information, and care for these men living with prostate cancer.

The BALANCE Study aims to give a voice to underrepresented groups and create a more fair and inclusive approach to prostate cancer research and care.

• We want to identify shortcomings in accessibility to information and care.
• We want to understand the unique challenges these men face by looking at how social, economic, and healthcare issues affect diagnosis, treatment, and overall quality of life.
• We want to make real change by using the findings to improve healthcare services and access to information, change policies, and improve clinical guidelines to better serve these men.

You have been sent or given this information because you are either of Black African or Black African-Caribbean ancestry or of Mixed Black ancestry, aged 18 years or over, have or had previously been diagnosed with prostate cancer yourself.

This study will be in the form of an electronic or paper questionnaire that will need to be completed once. Completion of this questionnaire can take up to 1.5 hours however, the average time has been one (1) hour. There will be an option within this survey for participants to be included in an interview sub-study. Participation in this sub-study is optional. If somebody declines taking part in the interview sub-study this does not affect their participation in the main questionnaire. 

Some questions in this survey are personal, so you may want to answer them in a private space. 

Your answers will stay confidential and pseudonymized (coded). Your answers will be grouped with answers from other participants. You will not be identified from the information you provide. 

The combined results might be shared in medical journals to help improve the lives of Black men with prostate cancer. You will not be identified. 

Before completing this questionnaire, it may be useful to have some of your prostate cancer tests, diagnosis and treatment letters from your healthcare provider, oncologist, or general practitioner at hand, as some questions might require you to refer to the letters for accurate answers.

The survey can be completed either online or on paper. If you decide to complete the survey online, you can go to the BALANCE page to access the survey directly. If you are completing this questionnaire electronically, please use the same browser on the same device for the entire duration of the survey to ensure consistency and data accuracy. If you are completing the questionnaire using the printed hardcopies, please return the completed form to your provider (the organisation that put you in touch with this survey). They will send all the completed forms back to the data centre for this study (located at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, UK). 

Some sections of this questionnaire may be more challenging to complete than others. If you need any assistance, please do not hesitate to contact a representative of the partner organisation which gave you this information.

If you participate in the study, this means we will collect and use your (medical) data. You can read below sub-sections about confidentiality.

You will not derive any (direct) benefit from participating in this study. However, your participation may contribute in the following ways:

• Giving them a voice: By sharing your prostate cancer experiences in this study you are making sure that men from the groups being represented in this study are seen and heard. Your participation helps show the needs and challenges of these groups, making your collected voices from these underrepresented groups stronger in healthcare and research discussions.
• Improving healthcare access: Data from this study could help point out where healthcare is lacking and push for better access to screenings, treatments, and support. This helps ensure that people from these underrepresented groups get the care they need when they need it.
• Tailoring treatments to their needs: By understanding how prostate cancer affects these groups differently, healthcare providers can create more personalised treatment plans. This means Black men and men of Mixed Black ethnic ancestry are more likely to get the care suited to their unique needs.
• Raising awareness and education: As the study highlights the higher risks for Black men and men of Mixed Black ethnic ancestry, it helps raise awareness in both the medical community and within these communities themselves. More knowledge can lead to earlier detection, better outcomes, and better-informed health decisions.
   
• Influencing policy and guidelines: The findings of this study can help change healthcare policies and clinical guidelines to address the specific needs of Black men and men of Mixed Black ethnic ancestry. This could lead to more supportive healthcare programmes and better research focused on improving their outcomes. 

Participation in the study will not affect your current treatment. Participants will receive the normal treatment or check-ups for their prostate cancer.

The disadvantages of participation are that they survey may involve some psychological discomfort, as completing the questionnaire could prompt participants to revisit distressing experiences related to their prostate cancer diagnosis and treatment. Additionally, for those who agree to take part in a follow-up interview, there will be a time commitment required.

Participation in the study is entirely voluntary, and it is up to you to decide whether to take part or not.

You are free to withdraw or decline from participating in the study at any time with or without giving a reason. We do ask that you notify the researcher as soon as possible. The data collected up to that point will still be used for the research.

If you have a concern about any aspect of this study, you should ask to speak to the study team who will do their best to answer your questions (contact number: 0208 722 4483). If you remain unhappy and wish to complain formally, you can do this through the Complaints Procedure at the European Association of Urology at info.patientinformation@uroweb.org.

All information collected about you during the study will be kept strictly confidential. Please see sub-section 9 below (How will my information be used?) for further information about confidentiality.

We will need to use information from you and from your medical records for this research project.

This information will include your:

• Name and email address (for future contact on sub-study, outcome of the BALANCE study, and future research);
• Gender
• Ethnicity;
• PSA-value;
• The tumour characteristics of your prostate cancer at diagnosis (such as T-stage, Gleason score);
• Which treatment you are currently having or which treatment you underwent;
• Quality of life, measured with the EORTC-QLQ-C30 questionnaire;
• Prostate-specific health, measured with the EPIC-26 and questions on use of medicines and devices for sexual functioning;
• Items on how you look back on the decision you made for treatment for prostate cancer, measured with the Decision Regret Scale.

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

The European Association of Urology (EAU) is the sponsor of this research.

The EAU is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• Ydeal – the online data collection platform running survey/questionnaire for this study.
• Erasmus MC University Medical Centre Rotterdam
• Support group(s) or prostate cancer charities that contacted you about this study.
• The Institute of Cancer Research
• The Royal Marsden NHS Foundation Trust
• Prostate Cancer UK
• A secure post company to assist us in sending study documents.
• Other collaborators – as part of this research study or future research studies.

We will keep all information about you safe and secure by:

• Using a unique study identifier number allocated to you to link all the data that you provide.
• Storing all your information securely.
• Treating your information as strictly confidential and nothing that might identify you will be revealed to any third party.
• Limiting access to your information to only those who need it for research or regulatory reasons and we will regularly review who has access to your information.
• Using strong encryption anytime we need to share your information.
• Ensuring everyone who has access to your information has been trained on how to use it in a safe way.
• Using a safe and secure online data collection platform called Ydeal to manage the survey/questionnaire used for this study.
• Using a secure courier and tracking service when posting study documents.
• Ensuring we adhere to our legal reason for using your information which is to carry out scientific research which is in the public’s interest.

We may share or provide access to data about you outside the UK for research related purposes to:

• advance knowledge about prostate cancer.

If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared where possible. This may not be possible under certain circumstances – for instance, if you have a rare illness, it may still be possible to identify you. If your data is shared outside the UK, it will be with the following sorts of organisations:

• Ydeal – the online data collection platform running survey/questionnaire for this study.
• Erasmus MC University Medical Centre Rotterdam
• A secure post company to assist us in sending study documents.
• Other collaborators – as part of this research study or future research studies.

We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:

• [some of] the countries your data will be shared with have an adequacy decision in place. This means that we know their laws offer a similar level of protection to data protection laws in the UK
• we use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website: https://ico.org.uk/for-organisations/uk-gdpr-guidance-and-resources/international-transfers/
• we do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says
• we need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing
• we have procedures in place to deal with any suspected personal data breach. We will tell you and applicable regulators when there has been a breach of your personal data when this is legally required. For further details about UK breach reporting rules visit the Information Commissioner's Office (ICO) website: https://ico.org.uk/for-organisations/report-a-breach

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
 

We will keep your study data for the minimum period of time required by the study sponsor on completion of the study, which is at least 5 years and up to a maximum of 25 years. The study data will then be fully anonymised and securely archived or destroyed.

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
• You have the right to ask us to access, remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.
• If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. This will be held at Erasmus MC University Medical Centre Rotterdam.

You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK:

• our leaflet: www.hra.nhs.uk/patientdataandresearch
• our privacy notice on our website: uroweb.org/privacy-policy
• by sending an email to Info.patientinformation@uroweb.org
• by asking one of the research team, or
• by ringing +31 26 3890 680.

If you decide to participate, you will not receive any compensation for completing the survey and participating in this survey.

This research is being organised by a team within the European Association of Urology and other collaborators headed by Professor Eamonn Rogers.

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee (REC) to protect your safety, rights, wellbeing, and dignity. This study has been reviewed by the London-Surrey Boarders Research Ethics Committee, who are the ethics committee regulating the conduct of this study. This study has also been reviewed by the Health Research Authority (HRA).

If you have any questions about this study, please contact the research team. The contact details can be found below