REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

Ottawa Hospital Research Institute142 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

142

Conditions

Breast Cancer

Interventions

G-CSFDRUG

CiprofloxacinDRUG

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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 (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: every 4 weeks up to 2 years

Secondary Outcomes

rates of febrile neutropenia

Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF

Time frame: Once when the last participant completes chemotherapy up to year 2

Data from ClinicalTrials.gov

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