Venous Thrombosis and Pulmonary Embolism
Conditions
Keywords
Cancer, Deep Venous Thrombosis, Pulmonary Embolism
Brief summary
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
Interventions
Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous \< 6 months or recurrent or metastatic cancer) * Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study * Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE * Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 * Patients who are willing to participate in this study (signed informed consent) * Patients who are available for follow-up with a life expectancy \>6 months
Exclusion criteria
* The contra-indications according to the local marketing authorization must be considered * Patients who developed an index VTE event despite chronic anticoagulant therapy * Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event * Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment satisfaction burden score (ACTS) | At 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of ACTS score over time | At 3 months and 6 months | To assess patient reported outcomes by means of the Anti-Clot Treatment Scale (ACTS) questionnaire |
| Patient's quality of life using the FACIT-Fatigue questionnaire | Up to 6 months | To assess patient reported outcomes on quality of life using the FACIT-Fatigue questionnaire (Functional Assessment of Chronic Illness Therapy) |
| Type of index VTE (venous thromboembolism) event | At baseline | — |
| Date of index VTE event | At baseline | — |
| Type (trade name) of initial anticoagulation treatment | At baseline | — |
| Duration of initial anticoagulation treatment | At baseline | — |
| Reason for drug switch to rivaroxaban | At baseline | Menu items: patient choice, physician choice, side effects, other |
| Planned duration of anticoagulation with rivaroxaban | At baseline | — |
| Actual duration of anticoagulation with rivaroxaban | Up to 6 months | — |
| Preferences regarding the attributes of the anticoagulation medication options LMWH, VKA, rivaroxaban using DCE survey | Between 4 weeks and 3 months | 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 |
| Reason for any potential dose adjustments during course of treatment with rivaroxaban | Up to 6 months | Menu items: side effects, intervention, other |
| Reasons for any switch from rivaroxaban treatment | Up to 6 months | Menu items: patient choice, physician choice, side effects, other |
| Reasons for permanent cessation of rivaroxaban treatment | Up to 6 months | Menu items: patient choice, physician choice, side effects, other |
| TNM Staging (Clinical characteristics of cancer disease) | At baseline | Assessment according to TNM (Tumor, Lymph Node and Metastases) classification. TNM is developed and maintained by the Union for International Cancer Control (UICC) |
| Primary site of cancer (Clinical characteristics of cancer disease) | At baseline | Following Medical Dictionary for Regulatory Activities (MedDRA) coding system |
| Type of bleeding events | Up to 6 months | — |
| Number of bleeding events | Up to 6 months | — |
| Type of thromboembolic events | Up to 6 months | — |
| Number of thromboembolic events | Up to 6 months | — |
| Dosage of rivaroxaban | Up to 6 months | — |
Countries
Australia, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed