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A study looking at a service to assess side effects of radiotherapy for prostate cancer (EAGLE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at developing a service to assess and help men who have side effects from having radiotherapy for their prostate cancer.
More about this trial
Radiotherapy is one of the treatments doctors use for prostate cancer. Like all treatments it can have side effects. Some side effects, such as bowel problems, can happen during the time you have radiotherapy or sometime after finishing. These side effects can cause significant problems with socialising, work, travel and other areas of the men’s life.
In this study researchers want to develop a new service to improve the wellbeing of men who have side effects from radiotherapy for prostate cancer.
The aim of the study is to introduce the service and find out if it does help men in this situation.
Who can enter
You may be able to join this study if you are being followed up in a clinic after having radiotherapy for your prostate cancer and all of the following apply. You
- Have new bowel or stomach symptoms caused by radiotherapy that are ongoing or have started at least 6 months after finishing treatment
- Are at least 18 years old
You cannot join this study if any of these apply
- Your prostate cancer has come back after being treated (has recurred)
- If English is not your first language and you have difficulty speaking or understanding English. If the clinic you go to has a translation service readily available you may be able to take part
This is a pilot study.
The researchers will ask all men who finished radiotherapy at least 6 months ago and who are going to a follow up clinic to register for the study. You fill in 1 or 2 short questionnaires. The questions will ask if you have had any problems with your bowels or stomach.
If you don’t have any problems you will continue with your normal care. By registering to take part and complete the questionnaires, the study team will be able to find out more about how many men have problems after radiotherapy.
If you have bowel or stomach problems caused by radiotherapy, you may be referred to a new specialist team that is part of the service being developed. This team will assess you and offer a suitable treatment. All men who are referred to the specialist team will be asked to join the EAGLE study. If you decline to join the study the specialist team will still see you.
The researchers need 300 men to join.
The team will ask you to fill out 4 short questionnaires when you join the study, at 6 months and a year. Each questionnaire will take about 10 minutes to complete. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They may also ask you to take part in an informal interview. They will ask about your personal experience of the EAGLE study and what effect it has had on your life. You don’t have to agree to the interviews. You can still take part in the main study.
The researchers would also like to interview someone who cares for you or gives you support, such as your partner, a friend, relative or companion. They will ask them about their experiences of caring and supporting someone who is in the study.
The interviews will take place at the start of the study, at 6 months and a year after starting. They will take between 30 minutes and 60 minutes. With your permission the researcher will take notes and record the interview on a small digital recorder.
The study team also want to follow up men who are having standard care for bowel and stomach problems after radiotherapy for prostate cancer. They will also ask them to complete the quality of life questionnaires. The researchers will compare their experiences with men who took part in the EAGLE study. This will help the researchers find out how useful the new service is.
The team will interview healthcare professionals, such as doctors and nurses, who are treating men as part of the EAGLE study. They want to find out what effect they think the service has had on the treatment of these men.
The interviews can take place either at your clinic appointments or if you prefer the researchers can phone you at home.
There are no side effects if you agree to take part in this study.
How to join a clinical trial
Dr Annemarie Nelson
Dr John Staffurth
Marie Curie Cancer Care
NIHR Clinical Research Network: Cancer
Prostate Cancer UK
Tenovus Innovation Grant