Extrait

Background and study aims It is very important that any side effects or symptoms 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 using the internet or telephone to report these symptoms and side effects. This means any problems can be recorded straight away, rather than waiting until the next clinic appointment. This project is testing whether an electronic system (using the internet or telephone) is acceptable and used by cancer patients receiving treatment to report any symptoms, side effects and their quality of life on a regular basis during a 3 month period. The research team have already spoken to patients about what types of questions to ask and this stage of the project aims to see how the system will work in practice -– for example whether patients use the system and how they find using it. What does the study involve? Patients are approached during their routine hospital appointments. The researcher explains the different ways of completing the symptom/quality of life questionnaires from home using the internet and/or telephone. Basic training is given on how to use the systems. Patients are asked to log in to one of the systems from home once a week for three months to answer questions about their symptoms and side effects. Once a month they are also be asked to complete some extra questions about their general quality of life. At the end of the study, patients may also be asked to take part in an interview or complete a feedback form to find out what they thought about the research and the symptom reporting system they used. What are the possible benefits and risks of participating? There are no immediate direct benefits to those taking part in this study, but the results will be used to help people with cancer in the future. There are no anticipated risks of taking part in this study -– it does not affect the usual care or treatment patients receive in any way. The study is not replacing usual care so all symptoms and side effects should continue to be reported to clinical teams in the usual way (e.g. emergency contacts). Where is the study run from? St James's University Hospital, St James's Institute of Oncology (UK) When is the study starting and how long is it expected to run for? July 2014 to January 2016 Who is funding the study? Cancer Research UK Who is the main contact? Dr Fiona Kennedy [email protected]

Critère d'inclusion

• Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All

Liens

• ictrp
• isrctn