REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
Conditions
Breast Cancer
Conditions: Keywords
Breast
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: G-CSF Type: Drug
Name: Ciprofloxacin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: 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
Location
The Ottawa Hospital
Ottawa, Ontario, Canada
Status: Recruiting
Contact: Mark Clemons, FRCP(UK) - 613-737-7700 - mclemons@toh.on.ca
Start Date
August 2014
Completion Date
September 2016
Sponsors
Ottawa Hospital Research Institute
Source
Ottawa Hospital Research Institute
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page