Extrait

Background and study aims Melanoma is a common skin cancer that can spread to other organs in the body. It Is the leading cause of skin cancer deaths in the UK. If the disease is not diagnosed early enough the cancer will spread and may result in death. Early, timely detection and prompt treatment can therefore make the difference as to whether someone recovers from melanoma or not. The use of a smartphone application for detecting skin changes could potentially assist in earlier diagnosis of melanoma, in prompting users to monitor their skin over time, and in suggesting professional, timely review of any suspicious moles detected. The purpose of this study is to test a novel skin self-monitoring (SSM) intervention (a smartphone app) in general practice aimed at promoting timely consulting by people that are considered to be at particular risk of developing melanoma. Who can participate? Patients aged 18-75 years old considered to be at higher than average risk of melanoma (roughly 25% of the UK population) will be recruited from GP practices in the East of England. What does the study involve? Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) have a standard consultation about prevention of skin cancer with the research nurse. They are then asked to use the SSM app for 12 months. Those in group 2 (control group) also have the consultation but are not given the SSM app. All participants in both groups are asked to complete a questionnaire about their health with the nurse and after 6 and 12 months. If participants go to see their GP or practice nurse about a skin change or mole during the study, they are also be asked to complete a questionnaire about why they decided to go. What are the possible benefits and risks of participating? Although there are no direct benefits for people taking part in this study, it is possible that they may find a skin change or mole that concerns them. If this happens, they are advised to make an appointment with their GP to have this checked. By taking part, participants will be contributing to research that could help patients and doctors in the future. Where is the study run from? The study is being organised by the Primary Care Unit, University of Cambridge and run in GP practices in the East of England. When is study starting and how long is it expected to run for? April 2016 to March 2018 Who is funding the study? National Institute for Health Research (UK) Who is the main contact? Dr Katie Mills [email protected]

Critère d'inclusion

• Melanoma

Liens

• isrctn
• ictrp