A Pragmatic Trial to Evaluate a Guideline Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile

Protocol: 
AAAR0311
Phase: 
N/A

A Pragmatic Trial to Evaluate a Guideline Based Colony Stimulating Factor Standing Order Intervention and to Determine the Effectiveness of Colony Stimulating Factor Use as Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile

This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the risk of infection. Colony stimulating factors are medications sometimes given to patients receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given to patients based on guidelines. Some clinics have an automated system that helps doctors decide when to prescribe them when there is a high risk of developing febrile neutropenia. Gathering information about the use of an automated system to prescribe prophylactic colony stimulating factor may help doctors use colony stimulating factor when it is needed.

Are you Eligible? (Inclusion Criteria)

1) Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer. Cancer may be metastatic or nonmetastatic (our site will only be accruing breast patients)

2) Patients must be registered prior to their first cycle of systemic therapy (chemotherapy,
immunotherapy, biologic therapy, or combination regimens) for this diagnosis. If patient has had any prior systemic therapy for another malignancy, patient must not have had any systemic
therapy in the 180 days just prior to registration.

3) Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim

4) Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current diagnosis.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States