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A study looking at a supported exercise programme for men with prostate cancer (STAMINA)
Cancer type:
Prostate cancer
Status:
Open
Phase:
Other
This study is looking at a supported exercise programme for men with prostate cancer. It is for men who are on or about to start androgen deprivation therapy (ADT).
More about this trial
The National Institute for Health and Care Excellence (NICE) recommends regular exercise for men with prostate cancer on hormone therapy.
Like all treatment hormone therapy has side effects. Some of the side effects such as tiredness (fatigue) can affect 
. The team think that an exercise programme with the help of an exercise specialist might reduce the side effects.
In this study half the men will follow a regular programme of exercise with support. The other half will have the usual care including a lifestyle support information package.
The aims of this study are to find out:
- whether a regular exercise programme improves the quality of life
- what is the best way to support men
Who can enter
The following bullet points are a summary of 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.
Who can take part
You may be able to join this study if you have prostate cancer and are:
- on hormone therapy or
- due to start hormone therapy within the next 12 weeks
Who can’t take part
You cannot join this study if any of these apply. You:
- have high blood pressure that isn’t controlled
- have diabetes that isn’t controlled
- have had a heart attack in the past 6 months
- have cancer spread to the bones that is unstable and is not responding to treatment
- are taking part in another study that looks at lifestyle
- have taken part in the STAMINA study already
Trial design
The team need 697 men to take part.
It is a randomised study. A computer puts you into 1 of 2 groups.
- STAMINA lifestyle intervention and optimised usual care
- Optimised usual care
STAMINA lifestyle intervention
You get free membership to your local Nuffield gym. A Clinical Exercise Specialist from the gym will contact you. They:
- arrange an introduction to the gym
- check your level of fitness
- set up an exercise programme
Over a year you attend a mixture of:
- supervised exercise sessions
- unsupervised exercise sessions
- one to one exercise sessions
- group exercise sessions
These can be either face to face or remote.
The researchers will tape record some of the conversations you and the Clinical Exercise Specialist have. They want to know how the Clinical Exercise Specialist is delivering the programme. Not what you are saying.
The team will also record any remote exercise session you have, this includes both sound and video. They will store your information in a secure area.
The team will ask 10 to 20 men to take part in an interview. They want to know about your experience of taking part in the exercise programme. You don’t have to agree to this. You can still take part in the main study.
Optimised usual care
You continue with your care in the usual way. This usual care promotes exercise according to The National Institute for Health and Care Excellence (NICE) guidance. It also includes a lifestyle support information pack.
Questionnaires
You fill in several questionnaires during the study. You can do this online or using a paper version. The team send out reminders when you need to fill in the questionnaires.
The questions ask about:
- your quality of life
- your general health and wellbeing
- how active you are
- what daily activities you can do
- side effects from hormone therapy
- what other health services that you used such as seeing your GP
Hospital visits
You or a member of the study team take the following measurements when you agree to take part and at regular times during the study:
- height and weight
- waist and hip
- blood pressure
- how many times you can get up from a chair in 30 seconds
You go to the hospital if the study team take the measurements. The team will show you what to do if you take the measurements yourself at home.
Side effects
The team don’t expect there to be any side effects if you take part.
Location
Cambridge
Chesterfield
Coventry
Derby
Liverpool
Nottingham
Plymouth
Redhill
Sheffield
Stockport
Yeovil
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Professor Derek Rosario
Supported by
National Institute for Health Research (NIHR)
Sheffield Teaching Hospitals NHS Foundation Trust
Freephone 0808 800 4040
Last review date
CRUK internal database number:
17002
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Keith took part in a trial looking into hormone therapy
