We have provided more detailed information about the study below for potential participants. These are similar to the official participant information leaflet which is given to potential participants interested in taking part. This document is available to be downloaded here. If you also want to view an example copy of the questionnaire that will be sent to participants this is available to download here. Additionally, we have further information available if you are concerned about your mental wellbeing during the study follow up on our Mental Wellbeing Resources page.
What is the purpose of the study?
The purpose of this study is to explore the impact a prostate cancer diagnosis and its various treatments have on a patient’s mental wellbeing and quality of life. The wellbeing and quality of life issues we are looking at include depressive and anxiety symptoms, body image issues, fear of recurrence, masculinity perception and functional issues such as bladder, bowel or sexual symptoms. More specifically, this study is aiming to look at how patients who undergo different management strategies for their cancer, experience these issues differently, and compare these groups directly. The four different treatment groups we are evaluating are:
- Active Surveillance
- Surgery (Radical Prostatectomy)
- Radiotherapy
- Hormonal Treatment
The reason for looking at this is because we want to better understand just how common these issues are in each treatment group, and which patients specifically are at greatest risk of having problems after a prostate cancer diagnosis. This would provide useful information for us on which patients may require further support during their cancer treatment.
This study is additionally being conducted as part of an educational project for a King’s College London student in part fulfillment of the award of a PhD degree.
Why have I been invited?
You have been invited to take part in the study because you have been recently diagnosed with prostate cancer. Patients from seven hospitals will be invited to take part, including King’s College Hospital (King’s College Hospital NHS Foundation Trust), Princess Royal University Hospital
(King’s College Hospital NHS Foundation Trust), Guy’s Hospital (Guy’s and St Thomas’ NHS Foundation Trust), Medway Maritime Hospital (Medway NHS Foundation Trust), Charring Cross Hospital (Imperial College Healthcare NHS Trust), Queen Elizabeth Hospital (Lewisham and Greenwich NHS Trust), East Surrey Hospital (Surrey and Sussex Healthcare NHS Foundation Trust) and Bedford Hospital (Bedfordshire Hospitals NHS Foundation Trust). We expect approximately 440 patients will take part in this study.
Do I have to take part?
It’s up to you to decide. We will describe the study to you and go through the information sheet with you. You will be able to keep a copy of the information sheet and think about taking part. You are free to discuss the information with anyone you wish including your family and friends. If you agree, we will then ask you to sign a consent form to show you have agreed to take part. You are free to withdraw at any time, without giving reason. This would not affect the standard of care you receive.
What will happen to me if I take part?
If you agree to take part in the study, we will ask whether you prefer to have all paperwork and study follow ups done via email or post. A member of the research team will contact you using a telephone number given to us by your clinical team and go over the study in detail, allowing you to ask any questions. If you are still happy to take part, we will then ask you to sign either an electronic or a physical consent form which has been sent to you depending on your stated preference when you were recruited. A signed copy of either of these will then be provided to you after this using the same method used to complete the form (i.e posted or emailed to yourself).
This study is purely observational, where you will receive no intervention or treatment for your prostate cancer outside of what will be given to you by your clinical team. We will instead follow you up for a total of 12 months using a series of questionnaires sent to you. These will be sent to you electronically via email, or physically through the post depending on your preference. The questionnaires would then be sent to you at the beginning of the study and then a further four times at 3, 6, 9 and 12 months after your cancer diagnosis. The same questionnaire will be sent to you at each of these time frames. It is estimated that on each occasion the questionnaires will take approximately 30 minutes to complete. Therefore, it is estimated that a total of two and a half hours of your time will be required over the duration of the 12 months of this study. A copy of the questionnaire will be provided to you with this information leaflet as a supplement. You can use this for consideration before deciding whether you wish to take part in the study or not. The questionnaires will ask you about recent symptoms you have experienced including depressive and anxiety symptoms, feelings about your body image, fears of your disease coming back or getting worse, your perceptions around masculinity and physical symptoms you have experienced including bladder, bowel and sexual function. In addition to this at the beginning and at the end of the study, the research team will also gain some extra information specifically about your cancer and the treatments you have received from your clinical records.
There will be no need for any physical follow up at a hospital site for the purpose of this study. We will only follow you up using the methods above. All data collected from yourself during this study will use secure data collection methods, be stored safely and study staff will protect your personal information closely so no one will be able to connect your responses and any other information that identifies you. At the end of the 12 months your involvement in the study will finish with no requirement for further questionnaires and we will subsequently inform you of the results of the study.
What are the alternatives for treatment?
Taking part in this study will not alter the treatment or follow up you receive for your prostate cancer. All treatments you receive will still be managed by your clinical team as per their decisions.
What are the possible benefits of taking part?
As no treatment is being received during the study itself it is unlikely being involved will benefit your own cancer outcomes. We therefore cannot promise the study will help you personally. However, the information we get from this study may help improve the future treatment of people with prostate cancer by helping us to identify who is most likely to need help during their cancer experience.
What are the possible disadvantages and risks of taking part?
As we will not be giving you any additional treatment or intervention affecting your care in this study there are no side-effect related risks from participating in this study. However, a disadvantage from participating is the inconvenience and time associated with completing the necessary questionnaires which we expect will require around 30 minutes at each time point. We aim to minimise this by sending these to you (by whichever means you selected at the outset) to complete at a time convenient to you. Additionally, the questionnaires will ask sensitive questions surrounding your mental health and symptoms such as bowel, bladder and sexual function, which some find distressing to share. Throughout the study we will keep these results confidential, ensuring your data is also secure through our data storage policy.
Lastly, as we will be following you with mental health questionnaires which are not usually part of the routine follow up procedure, we may identify mental health problems which would not otherwise be discovered. Whilst having mild depressive or anxiety symptoms are common, more severe symptoms including thoughts of suicide may well be identified in a very small proportion of participants. We have made a protocol on what would happen if these were identified in any of our participants. If we were to see features of severe depression or frequent suicidal thoughts, we would discuss these with yourself, and importantly, with either your usual clinical team or your General Practitioner, so that help can be given to you if needed. For those where we identify less severe depressive or suicidal symptoms, or where severe anxiety was seen we will contact you with further information on ways to seek self-help or how to make a self-referral locally. We will additionally have further resources available within our study website and a phone contact if you are concerned and would like to discuss any issues further. Details of both of these are available at the end of this document.
Who is organising and funding this study?
The doctor in charge of this study is Mr. Kamran Ahmed, an honorary consultant urological surgeon at King’s College Hospital and a Senior Clinical Lecturer at King’s College London. The study is funded by King’s College London through the King’s Medical Research Trust. The sponsor of the study is King’s College London, with King’s College Hospital NHS Foundation Trust acting as a co-sponsor. There are no payments made by us to your hospital/ doctor for including you in this study.
How have patients and the public been involved in this study?
In designing of this study, we have taken into account cancer patient opinions through discussion of the study at a South East London Consumer Research Panel for Cancer (SELCRP) meeting. The topic of research, questionnaires to be used, the frequency of sending questionnaires and the overall burden of the study were discussed with members of the panel. The feedback received has strengthened the view that this is an important topic during cancer care, has guided aspects of the design of the study and re-assured us that the burden of participation for those participating is seen as low overall in view of the potential benefits for future care.
Who has reviewed this study?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by the London – Harrow Research Ethics Committee (REC Reference: 20/LO/1136). It has also been approved by the Health Research Authority and each local hospital will also give confirmation that the study can go ahead.
Are there any expenses or payments made for participation?
As no costs are associated with participating in this study. There are no funds available for payments to those participating in this study. If you chose to participate through postal follow-up pre-paid envelopes will be provided for this purpose.
What happens when the research study stops?
At the end of the 12 months of follow up there will be no further need for you complete any further questionnaires. We will collect some final data from your clinical records at this point regarding your cancer and the treatment you received but you will not require to do anything further for this. We will subsequently inform you of the results of the study through the same method we have been following you up with (postal or email) and we will post the results of these on this website.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time; and if you would like to do so; please speak to any member of the research team. It is important to know that your decision to withdraw from the study will not affect any care you receive. If you withdraw your consent to participate, we will not send you any further questionnaires at future dates and we will not collect any further clinical data from your records.
If you withdraw your consent; De-identified information collected about you may be used if you are happy with this. You can however request for all information collected already during the study to be destroyed, provided this was still possible (i.e. provided your data has not been used for final analysis by this point)
Similarly, if you were to die during the 12 months you were being followed up for this study, we would contact your next of kin (as detailed in your medical records) and confirm that they are happy for us to use de-identified information collected about you up to that point. We would remove any information collected up to this point if your next of kin was not in agreement for this to be done.
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to a member of the research team who will do their best to answer your questions. The coordinating member of the research study (Mr. Oliver Brunckhorst) can be contacted through oliver.brunckhorst@kcl.ac.uk or through our dedicated study telephone on 07434672408 for the discussion of any issues. Alternatively, the responsible lead of the research project (Mr. Kamran Ahmed) can also contacted through kamran.ahmed@kcl.ac.uk. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints procedure by contacting your local Patient Advice Liaison Service (PALS) office. Details of your local office can be obtained by asking your study doctor, GP, telephoning your local hospital or looking on the NHS choices website. http://www.nhs.uk/pages/home.aspx
Every care will be taken in the course of this study. However in the unlikely event that you are injured by taking part, compensation may be available. In the event that something does go wrong and you are harmed during the research and this is due to someone’s negligence then you may have grounds for a legal action for compensation against King’s College London, but you may have to pay your legal costs.
Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated by members of staff or about any side effects (adverse events) you may have experienced due to your participation in the study the normal National Health Service complaints mechanisms are available to you. Please ask a member of the research team if you would like more information on this.
Will my taking part be kept confidential?
Study staff will protect your personal information closely so no one will be able to connect your responses and any other information that identifies you individually. However, national laws may require us to show information to university or government officials (or sponsors), who are responsible for monitoring the safety of this study. Directly identifying information (e.g. names, addresses) will be safeguarded and maintained under controlled conditions. You will not be identified in any publication from this study.
To ensure that the data we collect is secure during the study we will also:
- Store all data using secure password protected and encrypted devices which will be kept in safe locations at our King’s College London research offices. These are located at Guy’s Hospital and King’s College Hospital.
- All identifiable data we have from you including your name, contact details and date of birth will be kept separately from questionnaire data we collect from you so that this information is not linked to the sensitive data we collect.
- All sensitive data we keep will be de-identified, where we replace any identifying information with unique identifying codes. Only the research team will have access to information that identifies you to carry out this research study. Your identifying information will not be shared with others outside this research study
- All data including questionnaire data or clinical data collected from you, which is collected using electronic survey software will use secure transfer and storage of data principles. No identifying features collected which are linked to the sensitive information you provide us.
- All postal data collected, which includes the questionnaire sent to you if this is your chosen method of follow up, will also not contain your identifiable information with only your study ID used to ensure we know who the survey results belong to.
- We will not send your data externally to be analysed and the data will not be stored or sent outside the European Economic Area (EEA)
All information gained from the questionnaires will remain confidential and only used for subsequent analysis of data by members of the research team. However, as previously mentioned if during the follow up we identify severe mental health concerns about you where we are severely concerned we would subsequently contact your usual hospital team or your GP to discuss these with them. We would discuss this with you prior and would only be done so that concerns could then be addressed by a suitable healthcare professional.
How will we use information about you?
If you consent to take part, we will need to use information from you for conducting the research project. This will include your contact information, data we collect from your clinical records about yourself, your cancer and the treatment you have received, and the information you provide from the questionnaires we send you. This data will only be used to contact you during the study and for the analysis of the data to meet our research aims by members of the research team. As mentioned before de-identified data have to be shared to regulatory bodies to ensure the research is being done properly, however your personal information will be safeguarded.
Once the study has completed some of the data is required to be kept for 20 years as per King’s College London policy. We will keep identifying information only for a period of 1 year after the completion of the study, purely for the purpose of informing you of the results of the study. After this we will destroy this information. After this all data we keep will not contain any personal information that could identify you. This de-identified data will be kept for a minimum of 20 years after completion of the study. The de-identified data will subsequently be made publicly available through King’s College London data sharing website for the duration of the time it is kept. The purpose of this is purely to ensure that research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making. We do not plan to re-analyse this data during this period or apply for further ethics to re-use the data in any way. In addition, we will write any subsequent reports or publications arising from this study in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep de-identified information about you already collected to that point unless you request these to be withdrawn. Because we need to manage your records in specific ways for the research to be reliable, you can request to see the data we have about you (at your request), however, you won’t be able change the data we hold.
Where can you find out more about how your information is used?
If you consent to take part, we will use your data to deliver this project as described in the Patient Information Sheet. If you would like to find out more please read the supplementary leaflet provided, entitled ‘How we use your data’. Alternatively, you can find out more by asking one of the research team directly or by using the contact details at the end of this information sheet. Additionally, the Data Protection Officer for the Sponsor of the research (King’s College London) is Mr Albert Chan who can be contacted through info-compliance@kcl.ac.uk should you have any concerns about how your data is handled.
Will my General Practitioner be aware of my involvement in this study?
If you agree to participate in this study, we will send your GP a letter to inform them of your involvement in this study and what this involves. We will seek your permission for this to be done.
What will happen to the results of the research study?
We aim to publish the results of this study in peer reviewed journals and present these at national and international conferences. We will also be publishing the results of the study on this website and on social media once these are published. The study will also form part of a research student PhD thesis as part of their degree. We will also be sharing the results of the study to participants and on this website so you are aware what the results of the study are.
Where can I find out more information?
If you would like further information regarding the study, please do not hesitate to ask one of the members of the research team directly or through our study phone. They will be happy to answer any queries or direct you to the right individuals. Additionally, we have further information within our study website and where to seek help if you require this:
Chief Investigator: Mr Kamran Ahmed, Email: Kamran.ahmed@kcl.ac.uk
PhD Fellow/study coordinator: Mr Oliver Brunckhorst, Email: oliver.brunckhorst@kcl.ac.uk
MIND-P Research Team Contact Telephone Number: 07434672408 (Available Mon-Fri, 9:00-17:00)