S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)

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.

Sex

All

Minimum age

18 Years

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

• DERIVEDHershman DL, Bansal A, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Sullivan SD, Lyman GH, Ramsey SD. Intervention Nonadherence in the TrACER (S1415CD) Study: A Pragmatic Randomized Trial of a Standardized Order Entry for CSF Prescribing. JCO Oncol Pract. 2023 Dec;19(12):1160-1167. doi: 10.1200/OP.23.00219. Epub 2023 Oct 3. PMID 37788414
• DERIVEDLyman GH, Bansal A, Sullivan SD, Arnold KB, Barlow WE, Hershman DL, Lad TE, Ramsey SD. Impact of treatment experience on patient knowledge of colony-stimulating factors among patients receiving cancer chemotherapy: evidence from S1415CD-a large pragmatic trial. Support Care Cancer. 2023 Sep 28;31(10):598. doi: 10.1007/s00520-023-08056-z. PMID 37770704
• DERIVEDRamsey SD, Bansal A, Sullivan SD, Lyman GH, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Kreizenbeck K, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Hershman DL. Effects of a Guideline-Informed Clinical Decision Support System Intervention to Improve Colony-Stimulating Factor Prescribing: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238191. doi: 10.1001/jamanetworkopen.2022.38191. PMID 36279134
• DERIVEDHershman DL, Bansal A, Sullivan SD, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Ramsey SD. A Pragmatic Cluster-Randomized Trial of a Standing Order Entry Intervention for Colony-Stimulating Factor Use Among Patients at Intermediate Risk for Febrile Neutropenia. J Clin Oncol. 2023 Jan 20;41(3):590-598. doi: 10.1200/JCO.22.01258. Epub 2022 Oct 13. PMID 36228177
• DERIVEDWatabayashi KK, Bell-Brown A, Kreizenbeck K, Egan K, Lyman GH, Hershman DL, Arnold KB, Bansal A, Barlow WE, Sullivan SD, Ramsey SD. Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD. BMC Health Serv Res. 2022 Apr 1;22(1):432. doi: 10.1186/s12913-022-07835-4. PMID 35365139