TOPiC: Talking with men about treatment Options for Prostatic Cancer

This study has finished recruitment. We want to thank everyone who took part.

We will update this webpage with the results soon.

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Would you like to join a small discussion group for our new research study? 

We are inviting you to take part in a research study called TOPiC. The study is asking men to join group discussions to talk about how they feel about different types of treatment for prostate cancer. The types of treatment we will be discussing are all types of androgen deprivation therapy (sometimes called hormone therapy). Ultimately, we want to find out which treatment men feel they would choose if they ever needed ADT.

We are looking for the opinions of men with and without prostate cancer. We are currently focusing on the opinions of men who have never received androgen deprivation therapy, as we already have some information from men who have previously received androgen deprivation therapy.

Thank you for considering joining our research study.

If eligible, you will need to be available to spend 90 minutes in a group discussion.

We have currently conducted 5 focus groups. We have no further groups scheduled to take place.

You can find all of the information about the study in the participant information sheet which you can download here or continue to read the participant information below.

lease be aware that there are a limited number of focus groups planned and therefore a limit to the number of participants we can include. Once we have enough sufficient people to fill all the focus groups we will close the link to the consent form.

If you would like to find out any more information, please contact the trial team on: mrcctu.topic@ucl.ac.uk

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Information for participants considering taking part in focus group discussions

We are inviting you to take part in a research study looking at patient views on different types of treatments for prostate cancer.

Thank you for taking the time to read this information carefully. Discuss it with friends and family if you wish. Take time to decide whether or not you wish to take part in this study, it is your decision.

You can stop taking part in the study at any time, without giving a reason.

If anything is not clear or if you would like more information, please speak to the research team who will answer your questions.

If you have prostate cancer, whether you choose to take part in the study or not will not affect the care you get from your own doctors in any way.

If you decide to take part, you will be asked to sign an online consent form confirming your decision to take part in the TOPiC study. You will be emailed a copy of this information sheet and a copy of your signed consent form to keep for your records.

What is the project about?

Androgen deprivation therapy (ADT, sometimes called “hormone therapy”) is probably the most common treatment for men with advanced prostate cancer.  It is generally given as regular injections that reduce the amount of testosterone made in the body.  More men are having treatment with ADT for many years, and we know that these treatments can potentially cause side-effects and have other impacts on people’s lives.

Trials are currently testing new types of ADT, including a patch treatment and a tablet treatment. Each treatment seems to have slightly different side-effects and other impacts on men using the treatment.  It is not clear that any of the treatments are “better” than the others.

Depending on results from ongoing trials it is possible that, in the future, men who require ADT will have a choice between an injection, a tablet, or a patch treatment to control their prostate cancer.

What are we trying to find out?

The TOPiC study is looking at how men feel about different types of ADT.

Men who participate in the study will be given information about all the treatments (similar to the information you would be given in clinic if you were starting treatment).

We will ask how you feel about each treatment, which treatment you would choose if you ever had to start ADT and the reasons for this. 

We also want to discuss what factors you think are most important to consider when starting treatment, for example how the treatment is given, how quickly the medication wears off, or the side-effects of each treatment?

Why would we like to talk to you?

You are being invited to take part in this study because we would like the opinions of a wide range of men. We are interested in hearing your experiences and your views. There are no right or wrong answers. 

We hope that the TOPiC study will help us understand which information is most important to help men choose between treatment options with different types of ADT.  This should help us plan how we communicate information about different treatments.  In addition, it will help us understand whether men are interested in having different treatment options for ADT.

Who are we?

Our team is based at the Medical Research Council Clinical Trials Unit at University College London (UCL). The project lead is Dr Hannah Rush who is an oncology doctor and is completing research about prostate cancer that will contribute to a research degree at UCL.

What will be involved?

If you take part, you will first need to complete a consent form to indicate that you understand the study and agree to take part. To complete the consent form please follow the link at the bottom of this webpage. After completing the consent form we would like to ask for some basic information about your demographics and your health so we can see if different groups of men have different opinions on these treatments.

We will then invite you to a focus group discussion consisting of a group interview with around 4 to 6 other participants. For this study, the group interview may include either men who have prostate cancer or men who have not, but we will not include men who are already taking ADT.

We will have separate group discussions for men who have had prostate cancer. As we are discussing prostate cancer treatments, this will hopefully mean men who have had prostate cancer feel more comfortable talking even if it reminds them of their own experiences.

What will the focus group discussion be like?        

The focus group discussion will take around an hour and a half and will take place either online using Microsoft Teams or in person at UCL in London.  You don’t need to download any software to attend the meeting but will need to have access to the internet (via a computer, laptop, e-tablet or even smartphone).  You will be emailed a link to the focus group discussion which you should click on at the agreed meeting time. 

During the meeting, you will be given some information about the new types of ADT being developed and how these compare to current ADT options. We would then like to hear everyone’s thoughts and feelings about each treatment.

We will make a recording of the focus group so that we can remember what is said, but this will be saved in an encrypted form and only the research team will be able to access it.  The research team will analyse the topics discussed in the meeting, but this will be done using typed versions of the conversation with all names removed.

Is the research confidential?

Yes and No

What is NOT confidential?

We will ask people attending the focus group discussion not to share what other people have said. However, because there are other participants in the focus group, it is impossible to say that the information discussed will stay completely confidential. Therefore, it is important that you do not talk about anything that you do not wish to share with others.

If you decide to stop taking part during the focus group discussion, what you have said up until that point will still be included in the recording. Once the meeting has finished it will not be possible to withdraw your data as it will be an integral part of the conversation.

In exceptional cases, if during a focus group, someone tells the researcher about something that the researcher deems a medical risk or danger to the individual or someone else, then our duty to keep the information confidential can be outweighed by the need to disclose information in the public interest. In these circumstances the researcher may have to contact a relevant medical professional.

What IS confidential?

We will not feedback any of the information discussed in the focus group to anyone who provides medical care for you – for example your local GP or oncology team.

We will keep any direct identifiers (such as your name and contact details, which we need to gather to arrange the focus group) totally separate from the data we collect from you. We will not keep your name and contact details after the study has ended.

We might use some of your quotations, but will never use your real name or any personal details. Anonymised data (without names, so no one can tell who said what) will be stored and may be used for other studies, but will only be seen by researchers authorised by the researcher.

What will you gain?

You will probably not gain anything directly from participating and it will not affect your medical care in any way. However, your involvement could benefit others by helping us to communicate information about ADT more effectively and gain an understanding of whether men or certain groups of men are interested in new types of ADT.

What are the possible risks?

There is very little risk to taking part in this research study.  There is a small risk that something upsetting may come up during discussions.   If this happens, we will ask you if we can contact anyone to help support you, and we will give you information about appropriate support groups. 

Will you be compensated?

Yes, we will reimburse you with a £25 voucher for participating in the focus group.

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More information about taking part

Do I have to take part in this study?

No. It is up to you to decide whether or not to take part. If you decide to take part you will be asked to sign an online consent form. You should save a copy of this information sheet and you will have the opportunity to download your signed consent form for your records. If you decide not to take part in this study, this will not affect any aspect of the care or treatment you receive at your oncology clinic.

Can I stop taking part after I’ve joined the study?

If you decide to take part in this study, you can stop taking part at any time without giving a reason. However, the discussion will have been influenced by your input, and if you decide to stop taking part after the focus group has started what you have said up until that point will still be included in the recording. It will not be possible to remove this from the recording or analysis.

How will my data be stored and collected? 

The information you provide in the discussion and your personal details will be kept securely in an encrypted storage area provided by UCL. Only researchers directly involved in this study will have access to the data. As participation is anonymous it will not be possible for us to withdraw your data once the focus group is over.

University College London (UCL) is the sponsor for this study based in the United Kingdom. We will be using information from you in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. We will keep the recording and transcript from the focus group discussion for 10 years.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information at https://www.mrcctu.ucl.ac.uk/privacy/.

The UCL Data Protection Officer can be contacted by email: data-protection@ucl.ac.uk

How will my data be used in future and other research?

When you agree to take part in a research study, the anonymised information about your health and care may be provided to researchers running other research studies in this organisation and other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad, and they must demonstrate a strong scientific or other legitimate reason for requiring the data. Your information will only be used by organisations and researchers to conduct research in accordance with relevant legislation, ethics and NHS research policy requirements. This will not include anyone who will make a profit from research with your information.

The data will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research. It will not be used to make decisions about future services available to you, such as insurance.

What will happen to the results of this study?

We will publish a summary of the results on the website of the MRC CTU at UCL: https://www.mrcctu.ucl.ac.uk/. We will publish findings from this study in publications and reports so that anyone interested can see them. You can ask us for a copy of any publication. Your identity and any personal details will be kept confidential. No named information about you will be published in any report of this study.

Who is funding and organising this study?

This study is being organised by Dr Hannah Rush and will form part of her research degree at UCL.

University College London is the sponsor of the study and has overall responsibility for its conduct. University College London is responsible for ensuring the study is carried out ethically and in the best interests of the study participants.

What can I do if there is a problem during the study?

If you have any concerns about any aspects of the way you have been approached or treated by members of the research team while taking part in the study, UCL complaints mechanisms are available to you. Please email Professor Ruth Langley who is overseeing this project at mrcctu.ctuenquiries@ucl.ac.uk. If you feel your complaint has not been resolved, you can contact the Chair of the UCL Research Ethics Committee via the email address: ethics@ucl.ac.uk.

Who has reviewed this project?

This project has received ethical approval from the University College London Research Ethics Committee (Ethics ID 23347/001).

Local data and Protection Privacy Notice

The controller for this project will be University College London (UCL). The UCL Data Protection Officer provides oversight of UCL activities involving the processing of personal data and can be contacted at data-protection@ucl.ac.uk.

Further information on how UCL uses participant information in health and care research studies can be found in our ‘general’ privacy notice via the link here. This ‘local’ privacy notice sets out the information that applies to this particular study.

The information that is required to be provided to participants under data protection legislation (GDPR and DPA 2018) is provided across both the ‘local’ and ‘general’ privacy notices.

The categories of personal data used will be as follows:

• Demographics

• Medical history

The lawful basis used to process your personal data will be the performance of a task in the public interest. The lawful basis used to process special category personal data will be via explicit consent and for health care research. If we are able to anonymise or pseudonymise the personal data you provide we will undertake this and will endeavour to minimise the processing of personal data wherever possible.

If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact UCL at data-protection@ucl.ac.uk.

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How to contact us

If you have any questions or need any more information, please contact Dr Hannah Rush.

MRC Clinical Trials Unit at UCL
Institute of Clinical Trials and Methodology
90 High Holborn
2nd Floor
London
WC1V 6LJ

Email:  mrcctu.topic@ucl.ac.uk

Who to contact for independent general advice?

Patient Advice and Liaison Service (PALS)

Tel: 020 8423 8999 or email: helpline@patients-association.com

 Further information

• Link to consent form
• Link to participant information sheet 
• Trial team contact: mrcctu.topic@ucl.ac.uk