"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study developing a questionnaire that people could use at home to report problems they have during cancer treatment (REPORT UK phase 1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is the first stage in the development of a questionnaire that people can use at home to report any symptoms or side effects they have during clinical trials for cancer treatment. This study is supported by Cancer Research UK.
It is very important that any side effects or problems people have during clinical trials are reported. Doing this helps researchers to see how safe a treatment is. It also contributes to guidelines on how to prescribe a drug, and to information for patients.
In this study, researchers are developing a questionnaire that can be filled out from home. This means you can record any problems straight away, rather than waiting until the next clinic appointment when things may not feel as bad. The team would like to know how easy you think the questions are to answer. And, how you would feel completing the questionnaire online, through a telephone based system or when you come to clinic. The aim of this first part of the questionnaire development is to gather feedback on the questions the researchers are thinking of using.
You will not have any direct benefit from taking part in this study. But the results will be used to help people with cancer in the future.
Who can enter
This study was recruiting people being treated at St James’ Hospital in Leeds with
- Breast cancer
- Ovarian cancer
- Bowel (colorectal) cancer
- Food pipe cancer
- Stomach cancer
- Lung cancer
- Prostate cancer
But is now recruiting people from the University Hospital Bristol NHS Trust who are having surgery for cancer of the food pipe or stomach.
And you are having one or more of the following treatments aimed to either cure your cancer or treat the symptoms
You cannot enter this study if you
- Cannot read or understand English
- Have any mental health problem that is a cause for concern
- Have any condition that may affect how clearly you understand things (cognitive dysfunction)
This phase 1 study will recruit about 60 people. Everybody taking part will complete a questionnaire. This may either be on a touch screen computer or on paper, and will take about 15 minutes. You don’t need to have any experience of using computers to be able to take part.
You then have an interview with a researcher. This will take about half an hour. They will ask you
- What you did or didn’t like about the questionnaire
- If the questions were relevant to you
- If you understood the questions
- If you would use other words to describe your symptoms
- If it was easy to choose a response
- How easy you thought the questions were to answer
- How you would feel about completing the questionnaire in general
With your permission, they will make an audio recording of the interview. The team will treat all the information
The team will arrange to see you an hour before your next treatment or clinic appointment. Or, if you are in hospital they will arrange for you to have the interview whilst you are there.
You will not have any side effects as a result of taking part in this study.
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.
Professor Galina Velikova
Cancer Research UK
National Institute for Health Research Cancer Research Network (NCRN)
University of Leeds