REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: G-CSF (Drug); Ciprofloxacin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Ottawa Hospital Research Institute Official(s) and/or principal investigator(s): Mark Clemons, Doctor, Principal Investigator, Affiliation: The Ottawa Hospital Cancer Centre
Overall contact: Mark Clemons, Doctor, Phone: 613-737-7720, Ext: 70170, Email: mclemons@toh.on.ca
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.
Clinical Details
Official title: Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: The percentage of randomized patients in each physician's practice
Secondary outcome: rates of febrile neutropenia
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
- Willing to complete a survey
Exclusion Criteria:
• Contraindication to either Ciprofloxacin or G-CSF
Locations and Contacts
Mark Clemons, Doctor, Phone: 613-737-7720, Ext: 70170, Email: mclemons@toh.on.ca
The Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada; Recruiting Mark Clemons, FRCP(UK), Phone: 613-737-7700, Ext: 70170, Email: mclemons@toh.on.ca
Additional Information
Starting date: August 2014
Last updated: July 21, 2015
|