Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study looking at improving cancer treatment by using electronic questionnaires to ask people about the side effects of pelvic radiotherapy (OPTIMAL)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at using electronic questionnaires that people can complete from home, which may improve how side effects of radiotherapy are spotted, treated and monitored.
Doctors can treat anal cancer and cervical cancer, with radiotherapy, or a combination of radiotherapy and chemotherapy. If you have rectal cancer or womb cancer, you may have surgery, but you may also have radiotherapy. If you have radiotherapy to the area between your hip bones (your
Pelvic radiotherapy can cause side effects. It is important that doctors pick these up, so that people get the treatment and support they need.
In this study, researchers are looking at introducing an electronic system for people to report their side effects. They also want to get a better understanding of peoples’ experiences during and after radiotherapy treatment. The results may help to improve treatment and support for patients in the future.
Who can enter
You may be able to join this study if you are having (or have had) radiotherapy, or a combination of radiotherapy and chemotherapy, at St James’s Hospital Leeds for any of the following types of cancer
If you have had treatment for rectal cancer or womb cancer, you may be asked to take part if you are having your follow up appointments at hospitals in York, Harrogate, Bradford, Calderdale, Huddersfield or Mid Yorkshire.
There are 3 main parts to this study. In the 1st part, the researchers are looking at questionnaires that doctors already use. To begin with, they will talk to about 20 patients and 6 healthcare professionals.
If you take part, the study team will ask you to fill in a questionnaire either on a touch screen computer or on paper, and then have an interview with a researcher. In the interview, they will ask what you think of the questionnaire, if it is relevant to your own experience, whether you found it easy to answer the questions, and how you feel about filling it in. From this, they will select a questionnaire that patients could complete at home.
The researchers will then ask about 20 other people to complete the selected questionnaire. You can do this either using a touch screen computer in the hospital, or using your own computer at home (if you have one).
After filling in the questionnaire, the researchers will ask you what you think of it and whether you found it easy to read and understand. They will also ask if you found the questions relevant to you, and if there are any other questions you would like added.
In the 2nd part of the study, researchers are comparing the side effects people describe in questionnaires with the specific treatment they have. They need 370 people to join this part of the study.
If you agree to take part, the study team will ask you to complete a questionnaire either from home (if you have a computer and access to the internet) or on a touch screen computer in the hospital. Or if you prefer, you can fill in a paper questionnaire.
The study team hope to collect your answers before your next hospital appointment. This is because they would like your doctors and nurses to have this information when they next see you. But if you can’t complete the questionnaire before your next appointment, they would still be interested in your answers later on.
In the 3rd part of the study, about 130 people will complete questionnaires (either on a home computer, a hospital touch screen computer, or on paper if you prefer) between 7 and 9 times over 1 year. The researchers will compare your answers with the specific treatment you had, to see how they relate to each other. Taking part does not change the treatment you have.
Whichever part of the study you join, the researchers will get information about your cancer and its treatment from your medical notes. All the information they collect is
If you join the first part of the study, you will see the study team on a day that you have another appointment at the hospital. Or if you are an inpatient, they will talk to you while you are in hospital.
For the first 20 people, filling in the questionnaire and having the interview will take about an hour. The researcher will make an audio recording of the interview. If you join the study later and complete the selected questionnaire, it will take 15 to 20 minutes to fill it in and give your feedback.
If you join the 2nd part of the study, it will take about 15 minutes to complete the questionnaire.
If you join the 3rd part of the trial, it will take 10 to 15 minutes each time you complete a questionnaire.
There are no side effects from 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.
Dr Alexandra Gilbert
NIHR Clinical Research Network: Cancer
National Institute for Health Research (NIHR)
University of Leeds