REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
- Registration Number
- NCT02173262
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 142
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
- Willing to complete a survey
• Contraindication to either Ciprofloxacin or G-CSF
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciprofloxacin Ciprofloxacin Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia. G-CSF G-CSF Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.
- Primary Outcome Measures
Name Time Method The percentage of randomized patients in each physician's practice every 4 weeks up to 2 years The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.
- Secondary Outcome Measures
Name Time Method rates of febrile neutropenia Once when the last participant completes chemotherapy up to year 2 Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF
Trial Locations
- Locations (1)
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada