Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Ottawa Hospital Research Institute

Current Primary Outcome: 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. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rates of documented febrile neutropenia (laboratory confirmation) [ Time Frame: 1 year ]
  • ANC results at the end of each cycle of chemotherapy. [ Time Frame: 1 year ]
  • hospital admissions [ Time Frame: 1 year ]
  • percentage of patients who require chemotherapy dose delays [ Time Frame: 1 year ]
  • percentage of patients who require chemotherapy dose decrease [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Ottawa Hospital Research Institute

Dates:
Date Received: April 15, 2015
Date Started: May 2015
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016