COSIMO: Cancer associated thrombosis- patient reported outcomes
Research type
Research Study
Full title
COSIMO: Cancer associated thrombosis- patient reported outcomes with rivaroxaban
IRAS ID
225066
Contact name
Samuel Fatoba
Contact email
Sponsor organisation
Bayer
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is an international study conducted in Europe, Canada and Australia that aims to recruit 500 patients worldwide. It is non-interventional, meaning that data documented are routinely collected in daily practice from examinations or diagnostic tests; no additional examinations or tests need to be done.
The observation period for each patient is 6 months from enrollment into the study, or until withdrawal of consent or when no longer contactable.
It is a study of cancer patients with Deep vein thrombosis (DVT; blood clot) and/or Pulmonary Embolism (PE) changing to rivaroxaban for treatment of acute DVT and PE, and prevention of recurrent DVT and PE.The study aims to collect certain information from patients to help assess how satisfied they are with their treatment of blood clot or blood clot prevention using rivaroxaban therapy.
Patient’s treatment satisfaction with the previous standard of care (SOC) treatment (Low-molecular weight heparin- LMWH or Vitamin K antagonist- VKA) at baseline (when they enter the study) will be compared to prospective treatment with rivaroxaban using the Anti-Clot Treatment Scale (ACTS) questionnaire. The ACTS burden score at week 4 will be compared to the ACTS burden score at baseline. Patients with active cancer should have been treated for acute VTE for at least 4 weeks with SOC (LMWH or VKA) to be eligible for enrollment.
Information on patient preferences will be collected by means of structured questionnaires and a semi-structured telephone interview. The telephone interview would be conducted after a minimum of four weeks to a maximum of twelve weeks after enrollment of patients in the study/start of rivaroxaban.
Information on quality of life by means of the self-administered fatigue questionnaire will also be collected at baseline, as well as week 4, months 3, and 6 which are the time points of interest.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0208
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion