DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017