Bladder Cancer
Conditions
Brief summary
The goal of this randomized trial is to compare bladder cancer patient experiences taking prophylactic anticoagulation at home after surgery to remove their bladder. The main questions it aims to answer are: * Are patients equally adherent to apixaban as they are enoxaparin? Why or why not? * Do patients prefer apixaban or enoxaparin? * What is the typical patient cost to take apixaban vs enoxaparin after surgery? Participants will be randomized to receive a prescription for either enoxaparin or apixaban which they will then fill themselves and self-administer at home until post-operative day 30. They will receive phone calls from study coordinators at days 30 and 90 to complete questionaries over the phone to assess trial outcomes.
Interventions
OTHERapixaban
Participants will be randomized to receive a prescription for prophylactic apixaban
OTHERenoxaparin
Participants will be randomized to receive a prescription for prophylactic enoxaparin
Sponsors
Abramson Cancer Center at Penn Medicine
American Urological Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Able to communicate in English over the phone 4. Male or female, age \>18 years 5. Diagnosed with biopsy-proven, urothelial cell carcinoma (any T stage, N0-1, M0) with plan for radical cystectomy with urinary diversion and concurrent pelvic lymph node dissection as treatment
Exclusion criteria
1. Preoperative use of a therapeutic dose of anticoagulant (this notably does not exclude patients taking antiplatelet agents) 2. Failure to undergo radical cystectomy with concurrent urinary diversion and pelvic lymph node dissection 3. Failure to be discharged by post-operative day 14 4. Failure to receive a script for enoxaparin or apixaban. 5. Any medical condition which precludes treatment with either enoxaparin or apixaban (including dialysis, hemophilia or any other bleeding diathesis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence | Day of discharge to post-operative day 30 | proportion of days covered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | Day of discharge to post operative day 90 | patient out of pocket cost to fill their VTE prophylaxis prescription |
| Satisfaction as measured by 2. National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Medication Adherence Scale (PMAS) | Day of discharge to post-operative day 30 | patient satisfaction with their VTE prophylaxis drug |
| Reasons for non-adherence | Day of discharge to post-operative day 30 | patient-reported issues with adherence |
| VTE rate | Day of discharge to post-operative day 90 | rate of venous thromboembolism events |
| Bleeding rate | Day of discharge to post-operative day 90 | rate of major and minor bleeding events |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatharine F Michel, MD
University of Pennsylvania
Outcome results
None listed