A study looking at a new way to learn about the quality of life of men with prostate cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is using a handheld computer (a tablet) to learn about the quality of life of men with prostate cancer.
It is for men about to start treatment to slow down the growth of their cancer and to relieve any symptoms (
More about this trial
Men with prostate cancer often have problems related to their cancer and its treatment. This can have an impact on personal wellbeing and
It is important that your doctor knows about any problems you have. So they often ask you to complete quality of life questionnaires. These ask about:
- how you feel
- your symptoms
- the side effects of the treatment
These are usually paper questionnaires. But doctors want to find out if it’s possible for people to complete the questionnaires using a tablet computer.
The main aims of this study are to:
- learn more about the quality of life of men with prostate cancer
- find out if people can complete quality of life questionnaires using a tablet computer and how long this takes
- learn about the amount of support people need
- find out if it’s possible for people to use a tablet computer to sign the form that agrees to a clinical trial (
consent form). - find out if it’s possible for people to complete questionnaires at home using a computer of mobile phone
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply:
- You have prostate cancer that can’t be cured
- You are about to start treatment that reaches your whole body (systemic treatment)
- You are at least 18 years old
You cannot join this study if any of these apply:
- You have already started treatment
- You are taking dexamethasone, stilboestrol or an
anti androgen drug - You are having an experimental treatment as part of a clinical trial
Trial design
This is a feasibility study. Researchers hope that about 40 people will take part.
You complete a questionnaire using a tablet computer before the start of treatment and after 3 months. This takes between 20 to 30 minutes each time.
The questionnaire asks about:
- the symptoms related to your cancer
- the side effects of the treatment
- your quality of life
You don’t have to know how to use a tablet computer to take part in this study. The study team can show you how to do it.
Then you have a meeting or a telephone call with a study doctor. They ask you about the experience of completing a questionnaire using a tablet computer. This takes about 10 to 15 minutes.
Electronic consent form
You must sign a consent form before the start of this study. This is in a paper form.
Researchers might also ask you to sign the same form in a tablet computer. This is because they want to find out if it’s practical for people to give consent using an electronic consent form.
They will then ask you some questions about how you feel about the electronic consent form.
You do not have to agree to sign the electronic consent form if you don’t want to. You can still take part in this study.
Extra questionnaires
Researchers might ask you to complete more quality of life questionnaires 1 and 2 months after starting your treatment.
You complete the extra questionnaires at home. You can use:
- your mobile phone
- a computer tablet
- a laptop computer
- a desktop computer
The study team will send you a text or email to remind you about the questionnaires. And you have a link (a website) that you can access to complete them.
Again you don’t have to agree to complete extra questionnaires if you don’t want to. You can still take part.
Hospital visits
You don’t have any extra visits as part of this study. You complete the questionnaires when you are in hospital or when you have an outpatient appointment.
Side effects
You may find some of the questions distressing. The study doctors will be able to offer you support if you need it.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Duncan Gilbert
Dr Sally Appleyard
Supported by
Brighton and Sussex University Hospitals NHS Trust
Sussex Cancer Fund
Sanofi Pharmaceuticals
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
