The MPN Experimental Assessment of Symptoms by Utilizing Repetitive Evaluation (MEASURES) Trial: Serial Assessment of Symptomatic Response to Non Experimental Medical Therapies and/or Phlebotomy in Patients with Myeloproliferative Neoplasms
Guy’s and St Thomas’ NHS Foundation Trust
Myeloproliferative neoplasms (MPNs) are associated with a range of symptoms that can affect many different systems of the body. We have developed a diary designed to record the impact of symptoms in patients with MPNs. It is based on a previously tested questionnaire, the MPN symptom assessment form (MPN-SAF). This study aims to test the diary to see if it is effective at recording the impact of patients symptoms. In this study the diary will be completed by patients for seven days at the time of starting a new non-experimental treatment for a MPN. Patients will also complete several other quality of life assessment forms. After a minimum of 90 days of treatment (and maximum of 6 months), patients will then complete the diary and other quality of life assessments again. The patient’s doctor will be asked to provide information about the patient and their disease at the start of the trial. They will also be asked to give an assessment of the patient’s response to treatment and any side effects experienced by the patient after a minimum of 90 days of treatment (and maximum of 6 months). Eligible patients will have essential thrombocythaemia (ET), polycythaemia vera (PV) or myelofibrosis (primary or post ET or PV), be beginning a new non-experimental treatment for MPN and be willing to complete the diary. The trial is taking place at sites in several countries in Europe, South America, Australia and New Zealand, Canada and the USA. Patients will be in the study a maximum of 9 months, until the two diary entries have been completed. The study is being sponsored by the Guy's and St Thomas' NHS Foundation Trust.
London - Harrow Research Ethics Committee
Date of REC Opinion
8 Aug 2014
Further Information Favourable Opinion