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

Stage IV Breast Cancer Clinical Trial

Official title: 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 a Prophylaxis for Patients Receiving Chemotherapy With Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among patients registered at intervention components versus usual care components.

II. To compare the rate of febrile neutropenia (FN) among patients registered at intervention components versus usual care components.

III. To compare the rate of FN among intermediate risk patients registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

SECONDARY OBJECTIVES:

I. To compare the rate of FN among low-risk patients registered at intervention components versus usual care components.

II. To compare the FN-related health-related quality of life (HRQOL) among low-risk patients registered at intervention components versus usual care components.

III. To compare patient adherence to PP-CSF prescribing among patients registered at intervention components versus usual care components.

IV. To compare patient knowledge of the indications for, efficacy of, and side effects associated with PP-CSF between the initiation and conclusion of the first cycle of myelosuppressive systemic therapy among patients registered at intervention components versus usual care components.

V. To compare the proportion of patients completing the initial systemic therapy regimen at planned duration and at planned dose intensity among patients registered at intervention components versus usual care components.

VI. To compare antibiotic use both as prophylaxis and as treatment for FN among patients registered at intervention components versus usual care components.

VII. To compare the rate of FN-related emergency department visits and hospitalizations among intermediate risk patients registered to Intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

VIII. To compare the FN-related health-related quality of life (HRQOL) among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

IX. To compare overall survival among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not).

TERTIARY OBJECTIVES:

I. To characterize and descriptively report the differences among cohort components and the intervention and usual care components.

II. To evaluate the time to invasive recurrence in non-metastatic patients by component treatment assignment

OUTLINE: Patients are randomized to 1 of 4 clinic groups.

CLINIC GROUP 1 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 2 (CLINIC WITH NO AUTOMATED SYSTEM): Patients receive CSF based on clinical practice guidelines.

CLINIC GROUP 3 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high or moderate risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN.

CLINIC GROUP 4 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSF not be used for drugs that have a moderate risk of FN.

After completion of study treatment, patients are followed up for 12 months. ;

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Febrile Neutropenia
• Fever
• Hyperthermia
• Lung Neoplasms
• Neutropenia
• Stage 0 Breast Cancer
• Stage 0 Colorectal Cancer
• Stage 0 Non-Small Cell Lung Cancer
• Stage I Colorectal Cancer
• Stage IA Breast Cancer
• Stage IA Non-Small Cell Lung Carcinoma
• Stage IB Breast Cancer
• Stage IB Non-Small Cell Lung Carcinoma
• Stage IIA Breast Cancer
• Stage IIA Colorectal Cancer
• Stage IIA Non-Small Cell Lung Carcinoma
• Stage IIB Breast Cancer
• Stage IIB Colorectal Cancer
• Stage IIB Non-Small Cell Lung Carcinoma
• Stage IIC Colorectal Cancer
• Stage IIIA Breast Cancer
• Stage IIIA Colorectal Cancer
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Breast Cancer
• Stage IIIB Colorectal Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IIIC Breast Cancer
• Stage IIIC Colorectal Cancer
• Stage IV Breast Cancer
• Stage IV Non-Small Cell Lung Cancer
• Stage IVA Colorectal Cancer
• Stage IVB Colorectal Cancer

• NCT number: NCT02728596
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Completed
• Phase: N/A
• Start date: October 7, 2016
• Completion date: August 12, 2021