Life After Prostate Cancer Diagnosis Research Study If you are looking at this information sheet this means you have read the covering letter and therefore have had a diagnosis of prostate cancer. If you have not had a diagnosis of prostate cancer please return the documents in the envelope provided and they will be destroyed. We have brought this point up again as we are very concerned that contacting men who have not had a prostate cancer diagnosis may lead to misunderstanding and unnecessary worry. You are being invited to take part in a research study. Before you decide whether to take part, it is important that you understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Please get in touch using the numbers at the end of this leaflet if there is anything you are not clear about or if you would like more information. Thank you for reading this. What is the Life After Prostate Cancer Diagnosis study about? We know that prostate cancer is the most common cancer to affect men in the United Kingdom. Each year, approximately 1,000 men in Northern Ireland are diagnosed with prostate cancer, and the risk of developing the disease increases with age. We understand that treatment for prostate cancer can affect men s lives in many different ways. It can also affect their partners or spouses. We want to develop our understanding of men s health and wellbeing and how these may be improved. We want to find out directly from men how a prostate cancer diagnosis and treatment have affected their everyday lives: physically, emotionally, socially and practically. To do this we will be asking men to complete questions, known as Patient Reported Outcome Measures (PROMs) asking them about their experiences. We want to hear from as many men as possible whatever their age, stage of prostate cancer, whether they have symptoms or not and no matter what other medical conditions they may have. All opinions are important. Whyhave I been chosen? We are sending this survey in the post to all men living in Northern Ireland who we believe were diagnosed with prostate cancer 18-42 months ago. Surveys will also be posted out to men in Scotland and Wales. Men in England were surveyed last year. 1
What do we want the research to find out? In total, around 100,000 men will be sent a survey in the post over the next three years. For the first time ever, this research will give us a very clear and detailed picture of what life is like for men with prostate cancer across the UK. It should tell us how it changes over time, what helps men cope, what gaps there are in support and care services and whether any of these issues change depending on what part of the country you are from. By collecting information about the experiences of men who have been diagnosed with, treated for and are living with and beyond prostate cancer across the UK, we hope the results will be able to be used to improve the lives of men diagnosed with prostate cancer now and for men diagnosed with prostate cancer in the future. Why are we doing this study? We know that quality of life after prostate cancer isn t a level playing field not everyone experiences the same issues and side effects. We want to gather enough information to identify specific factors, such as physical or emotional issues, that put some men at greater risk of poorer wellbeing after prostate cancer. What would I have to do? We would like you to complete the enclosed survey. The questions will ask for information about you, your diagnosis and any treatment you may have had, symptoms and side effects, and your overall physical, emotional and social well-being. It will probably take about 30 minutes to complete, but you don t have to answer them all in one go. We want everyone to answer the questions even if they don t have any problems as it is important for us to know this. Many men who have had prostate cancer diagnosis and its treatment experience problems with a number of quite personal issues. It is important we have good information about the extent and severity of these problems to help provide better support in the future. Please be assured that all responses are kept completely confidential. We hope you will feel comfortable in responding to all the items in the survey but if you would rather not complete some questions you can simply leave them blank and move on to the next one. Once completed, please post the survey back to us in the pre-paid envelope enclosed. By sending it back to us, you are agreeing to take part in the study and that your answers can be analysed with the other men s answers (anonymously) by the research team. Please keep this information sheet and the letter enclosed as a record of your involvement. Taking part will not involve visits to the hospital. 2
Do I have to take part? No. It is up to you to decide whether or not to take part and if you decide not to, your decision will not affect any care you may receive or your statutory rights either now or in the future. If you do not wish to take part, please send this survey back uncompleted in the envelope provided, so that we can register your response and avoid contacting you again. Will you contact me again? If we do not hear back from you, we will send two reminders to you in the post. If you would prefer not to receive a reminder, you can register this by sending the survey back in the envelope uncompleted or by phoning the helpline. If you take part in this survey, we will contact you again in 12 months time, with an invitation to take part in a follow-up survey. This will allow us to see if anything has changed for you during this time. We will also be inviting a small number of men and their partners/spouses to participate in telephone interviews. Men and their partners/spouses will be invited only if they indicate at the end of the survey that they are interested in being interviewed. We are sorry we will not be able to contact all those who would like to participate in the interview and in cases where men and their partner/spouse are willing to be interviewed we may not be able to interview both. However, if you are one of the group we would like to interview we will write to you with more information and explain how to get in touch with us to find out more about the interview. What will happen to the information I give? All the survey responses will be completely anonymous and there will be no way to identify any individual man from his answers. The information you give will be analysed by the research team to learn more about which groups of patients are experiencing difficulties in the time after their cancer diagnosis and to identify risk factors which will allow support and aftercare services to be offered where they are most needed. What do we want to do with the results of this work? We expect that when this project finishes in three years time, we ll know far more about what life is like for men with prostate cancer - not only across the UK, but also in different parts of each country - depending on what treatment they ve received and how long ago they were treated. We ll be able to understand what men say has most affected their lives after a prostate cancer diagnosis and what needs to happen to improve any unwanted effects. We want to tell both men and the clinicians treating them about the results of this research. In the future, knowing what other men think has most affected their life after treatment may help men with 3
a prostate cancer diagnosis to choose the treatment that s right for them, as well as helping their doctors to counsel them appropriately. We also want to use the results we get from this project to influence governments and health providers in all UK nations at all levels - from national decision makers to local hospitals to make sure they provide the support and care men say is important to them. The results of the research study will be published in academic journals and shared with NHS teams, commissioners and policy makers. Updates on the study and summary results will be posted on the Life After Prostate Cancer Diagnosis website as the work progresses (www.lifeafterprostatecancerdiagnosis.com). No individual patient will be identified in any report or publication, it will be entirely anonymous. What are the disadvantages of taking part? We do not foresee any disadvantages to your taking part in the study. It will not affect your care or treatment in any way. If reflecting on your situation causes anxiety or uncertainty in any way, please do not hesitate to contact your specialist cancer nurse or call one of the Prostate Cancer UK Specialist Nurses via their confidential telephone service (0800 074 8383 free from UK landlines). They are there to listen to your concerns, and offer support and helpful information (Monday Friday 9-6pm, Wednesday 10-8pm). What are the benefits of taking part? There are no medical benefits to your taking part in this research study. Some people gain satisfaction from feeling that they are helping others with cancer in the future. Many patients find taking part in research a positive experience. Will my taking part in the study be kept confidential? Yes. It is very important to us to respect your information (data) and keep it confidential. We work within strict rules covering data protection and confidentiality. Before you were sent a questionnaire, the NHS Trust involved in your treatment was given an opportunity to consider whether it was appropriate to invite you to participate. This process may have involved your NHS Trust looking at some of your personal information that it holds on you. On the front of the questionnaire you will see a unique study ID number. The purpose of this ID number is to protect your identity. When you return the survey, the information you provide will be checked to see that your responses have not inadvertently disclosed your identity. The anonymised information, alongside your ID number, will be entered onto an electronic database by the approved survey provider, Picker Europe. Your survey will be stored securely by Picker Europe for 15 years from completion of the study, for audit purposes only. Picker Europe will destroy it after this date. 4
Picker Europe will securely share the anonymised information on the database it has created with the Northern Ireland Cancer Registry, who have approvals to work with cancer patient data. In order to fully analyse and interpret the results, the information you give will be linked to other information held about you in existing NHS databases, and the research team will receive anonymised disease and treatment information linked to your survey responses and identified only by your unique study ID number. Your personal information and survey responses will be stored as part of the patient cancer record by the Northern Ireland Cancer Registry under the strict data handling rules for patient identifiable information. The Research Team will not know your identity. By completing this questionnaire you are giving your consent for the information provided to be used for the purposes set out above. What if I change my mind? If you wish to withdraw from the study and have any personal information that identifies you deleted, you may do so by contacting the Life After Prostate Cancer Diagnosis helpline number (0808 801 0678), or the Project Office in Belfast (02890 971631). You do not need to give a reason why you want to withdraw. Your withdrawal will not affect any care you may receive or your statutory rights either now or in the future. No further information will be sought and we will not contact you again. If you wish to withdraw from the study, please phone the above numbers within 6 months from the date we first wrote to you. This 6-month window recognises that the research team will start using the information you have provided as soon as possible and that it may become difficult to identify what information does relate to you later on. Who has reviewed the study? The study has been reviewed by people who have experience of prostate cancer themselves as well as independent experts in this area of research. All health research is carefully considered and approved by a Research Ethics Committee an independent group of people that works to protect your interests (REC reference 15/NE/0036). Who is funding and organising this study? This study is funded by Prostate Cancer UK (PCUK) in partnership with the Movember Foundation Health Outcomes Improvement Initiative. The study is being coordinated by an experienced group of researchers from across the UK with medical, nursing, scientific and patient backgrounds. The team is supported by a prostate patient advisory group and a clinical advisory group. Prof Adam Glaser from the University of Leeds and Dr Anna Gavin from Queen s University Belfast are the Chief Investigators. The organisations involved are Public Health England, the University of Leeds, 5
Queen s University Belfast, University of Southampton and Oxford Brookes University. University of Leeds are sponsoring the study. The Where can I get more information about the study? The full protocol and information regarding the process of obtaining ethical approval are all available on the study website (www.lifeafterdiagnosis.com). The information includes specific details of the data processor and data controller, and all organisations involved in the study. What if there is a problem? If you have a concern or questions about any aspect of the Life After Prostate Cancer Diagnosis study, please telephone: Life After Prostate Cancer Diagnosis survey helpline on 0808 801 0678 Alternatively, if you wish to make a complaint, you may prefer to contact your local Health and Social Care board. Your Patient and Client Council can also provide free and confidential advice, information and help regarding a complaint For any prostate cancer specific problems please do not hesitate to contact your specialist cancer nurse, or call one of the Prostate Cancer UK Specialist Nurses via their confidential telephone service (0800 074 8383 free from UK landlines). They are there to listen to your concerns, and offer support and helpful information (Monday Friday 9-6pm, Wednesday 10-8pm).The prostate cancer UK Specialist Nurses can also be contacted by email, live chat or SMS. Details can be found here http://prostatecanceruk.org/get-support/our-specialist-nurses.. Thank you for reading this information sheet and considering taking part in this study. 6