This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
Study Type
OBSERVATIONAL
Enrollment
528
Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label
Unnamed facility
Multiple Locations, Australia
Unnamed facility
Multiple Locations, Belgium
Unnamed facility
Multiple Locations, Canada
Unnamed facility
Multiple Locations, Denmark
Treatment satisfaction burden score (ACTS)
Patient reported treatment satisfaction will be assessed with regard to the Anti-Clot Treatment Scale (ACTS) burden score for the use of rivaroxaban for treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in patients with active cancer changing to this therapy.
Time frame: At 4 weeks
Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey
Discrete Choice Experiment (DCE) based preference of patients for rivaroxaban versus other anticoagulants in a semi-structured telephone interview LMWH: Low Molecular Weight Heparin; VKA: Vitamin K Antagonist
Time frame: Between 4 weeks and 3 months
Change of ACTS score over time
To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire
Time frame: At 3 months and 6 months
Patient's quality of life using the FACIT-Fatigue questionnaire
To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy)
Time frame: Up to 6 months
Type of index VTE (venous thromboembolism) event
Time frame: At baseline
Date of index VTE event
Time frame: At baseline
Type (trade name) of initial anticoagulation treatment
Time frame: At baseline
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Unnamed facility
Multiple Locations, France
Unnamed facility
Multiple Locations, Germany
Unnamed facility
Multiple Locations, Italy
Unnamed facility
Multiple Locations, Netherlands
Unnamed facility
Multiple Locations, Spain
Unnamed facility
Multiple Locations, United Kingdom
Duration of initial anticoagulation treatment
Time frame: At baseline
Reason for drug switch to rivaroxaban
Menu items: patient choice, physician choice, side effects, other
Time frame: At baseline
Planned duration of anticoagulation with rivaroxaban
Time frame: At baseline
Actual duration of anticoagulation with rivaroxaban
Time frame: Up to 6 months
Dosage of rivaroxaban
Time frame: Up to 6 months
Reason for any potential dose adjustments during course of treatment with rivaroxaban
Menu items: side effects, intervention, other
Time frame: Up to 6 months
Reasons for any switch from rivaroxaban treatment
Menu items: patient choice, physician choice, side effects, other
Time frame: Up to 6 months
Reasons for permanent cessation of rivaroxaban treatment
Menu items: patient choice, physician choice, side effects, other
Time frame: Up to 6 months
TNM Staging (Clinical characteristics of cancer disease)
Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC)
Time frame: At baseline
Primary site of cancer (Clinical characteristics of cancer disease)
Following Medical Dictionary for Regulatory Activities (MedDRA) coding system
Time frame: At baseline
Type of bleeding events
Time frame: Up to 6 months
Number of bleeding events
Time frame: Up to 6 months
Type of thromboembolic events
Time frame: Up to 6 months
Number of thromboembolic events
Time frame: Up to 6 months