A study to improve how we collect information about side effects of cancer treatment (PRECIOUS)

Please note this trial is no longer recruiting patients.

This study will test a questionnaire looking at side effects during and after radiotherapy for womb, cervix and prostate cancer.

Radiotherapy uses radiation to destroy cancer cells in the treated area. But sometimes damage to nearby healthy cells can cause both short term side effects and long term side effects. As more people are living longer after radiotherapy they are more likely to have long term side effects, which may affect their quality of life.

The more doctors understand about these long terms side effects, the better they will be able to recognise and treat them. The researchers in this study have developed a questionnaire that helps identify difficulties people have following their treatment. They would like to test these questionnaires with patients. And see how easy it is to complete them electronically, instead of on paper. The aims of this study are to

Test how accurately the questionnaires identify treatment side effects
Find out how practical the electronic questionnaires are
See if the electronic questionnaires gain as much accurate information as paper questionnaires

Recruitment

Start 01/07/2007

End 05/06/2010

Phase

Pilot

Who can enter

You can enter this study if you

Have cancer of the womb (uterus), cervix or prostate
Are having radiotherapy on its own, or with chemotherapy (‘chemoradiation’) to cure your cancer
Can read and speak English very well
Are at least 18 years of age

You cannot enter this study if you have an illness that will eventually cause death (you are ‘terminally ill’).

Trial design

This is a pilot study. It will recruit 104 people. If the results are promising, both types of questionnaire will be used more widely.

This study will divide people into 2 groups. Everyone will complete paper and electronic questionnaires. The questionnaires will ask you about any side effects you have had and about how you have been feeling.

The order you complete the paper and electronic questionnaires depends on the group you are in. You will fill out one version at your radiotherapy planning appointment and the other on the 3rd day of your radiotherapy. Everyone will also answer a set of questions asking what they thought about the questionnaire content and method (a ‘feedback survey’).

You will have further paper and electronic questionnaires to complete (on different days) at the end of your course of treatment and again one year and 2 years later.

Hospital visits

You will fill out these questionnaires either at your hospital appointments or by post. So you will not need to make any extra hospitals visits to take part in this study.

Side effects

As there are no treatments in this study, there are no side effects. But you may find talking about your experiences upsetting. If this happens, the research nurse will talk your feelings through with you. They may also refer you for further support if you agree to this.