S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) (TrACER)
Febrile Neutropenia, Stage 0 Breast Cancer, Stage 0 Colorectal Cancer
About this trial
This is an interventional health services research trial for Febrile Neutropenia
Eligibility Criteria
Inclusion Criteria:
- Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic
- Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage 9or disease setting).
- Patients must not have had any systemic therapy (chemotherapy or combination regimens) in the 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors, and hormonal therapy are allowed.
- Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted. This treatment may be neoadjuvant or adjuvant chemotherapy.
- Patients must not be receiving or planning to receive concurrent radiation during systemic treatment.
- 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
- Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish
- Patients may have had a prior malignancy
- Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
- Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Sites / Locations
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- NEA Baptist Memorial Hospital
- Contra Costa Regional Medical Center
- Augusta University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Queen's Medical Center
- Tripler Army Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- John H Stroger Jr Hospital of Cook County
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Cancer Care Specialists of Illinois-Swansea
- Carle Cancer Center
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Cancer Center of Kansas-Liberal
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Wichita
- Cancer Center of Kansas - Winfield
- Louisiana State University Health Science Center
- University Medical Center New Orleans
- Louisiana State University Health Sciences Center Shreveport
- Saint Joseph Mercy Hospital
- Saint Joseph Mercy Brighton
- Saint Joseph Mercy Canton
- Saint Joseph Mercy Chelsea
- Ascension Saint John Hospital
- West Michigan Cancer Center
- Saint Mary Mercy Hospital
- William Beaumont Hospital-Royal Oak
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Essentia Health Cancer Center
- Sanford Thief River Falls Medical Center
- Sanford Cancer Center Worthington
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Centerpoint Medical Center LLC
- Research Medical Center
- Mercy Hospital Saint Louis
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Bozeman Deaconess Hospital
- CHI Health Saint Francis
- University of New Mexico Cancer Center
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Christus Saint Vincent Regional Cancer Center
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Novant Health Oncology Specialists-Kernersville
- Novant Health Oncology Specialists-Mount Airy
- Novant Health Oncology Specialists-Statesville
- Novant Health Oncology Specialists-Davidson County
- Novant Health Oncology Specialists-Wilkesboro
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Sanford Bismarck Medical Center
- Essentia Health Cancer Center-South University Clinic
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Dayton Physicians LLC-Miami Valley South
- Adena Regional Medical Center
- Dayton Physician LLC-Miami Valley Hospital North
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Greater Dayton Cancer Center
- Dayton Physicians LLC-Signal Point
- Dayton Physicians LLC-Wilson
- Dayton Physicians LLC-Upper Valley
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- Geisinger Cancer Services-Pottsville
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- MGC Hematology Oncology-Union
- Sanford Cancer Center Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Baptist Memorial Hospital and Cancer Center-Collierville
- Integrity Oncology PLLC-Collierville
- Baptist Memorial Hospital and Cancer Center-Memphis
- Family Cancer Center-Memphis
- Meharry Medical College
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Dixie Medical Center Regional Cancer Center
- MultiCare Auburn Medical Center
- Swedish Cancer Institute-Edmonds
- MultiCare Gig Harbor Medical Park
- Swedish Cancer Institute-Issaquah
- MultiCare Good Samaritan Hospital
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-First Hill
- Swedish Medical Center-Cherry Hill
- MultiCare Tacoma General Hospital
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Marshfield Medical Center-EC Cancer Center
- Marshfield Clinic - Ladysmith Center
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- Marshfield Medical Center-Rice Lake
- Marshfield Clinic Stevens Point Center
- Marshfield Clinic-Wausau Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Doctors Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Experimental
Experimental
Clinic group 1 (clinics with existing automated system for CSF prescribing)
Clinic group 2 (clinics with no automated system for CSF prescribing)
Clinic group 3 (clinics with automated system for CSF prescribing)
Clinic group 4 (clinics with automated system for CSF prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.