REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

Breast Cancer Clinical Trial

— OTT14-03  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173262
• Other study ID #: 20140380-01H
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2014
• Last updated: October 31, 2017
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• G-CSF

• Ciprofloxacin

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of randomized patients in each physician's practice	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.	every 4 weeks up to 2 years
Secondary	rates of febrile neutropenia	Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF	Once when the last participant completes chemotherapy up to year 2