A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)

Study Overview
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Brief Summary
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In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of febrile neutropenia, such as Neupogen (Filgrastim) as a daily injection for 5, 7, or 10 days. Since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of Neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of Neupogen daily injection. Neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. In addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. This study will use an integrated consent model that involves an oral consent rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. While determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.

Official Title
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A Multi Centre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Standard of Care Administration Schedules of G-CSF (Filgrastim) for Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia in Early Stage Breast Cancer (React-G Study)

Conditions
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Early Stage Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed primary breast cancer Planned to start docetaxel component of FEC-D or AC-D, or first cycle of; dose-dense AC-T, TC, FEC-D or TAC chemotherapy ≥19 years of age Able to provide verbal consent Exclusion Criteria: Contraindication to Filgrastim

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 5 days of filgrastim<br>Standard of care | |
| 7 days of filgrastim<br>Standard of care | |
| 10 days of filgrastim<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of performing this study will be measured with composite endpoints: physician engagement, time for local or provincial research ethics approval, accrual rates, and patient/physician compliance. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of documented febrile neutropenia (laboratory confirmation) |  | 1 year | 
| ANC results at the end of each cycle of chemotherapy. |  | 1 year | 
| hospital admissions |  | 1 year | 
| percentage of patients who require chemotherapy dose delays |  | 1 year | 
| percentage of patients who require chemotherapy dose decrease |  | 1 year |