CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,665 enrolled
Drug / intervention
Preventive Intervention +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02728596
NCT02728596N/ACompleted
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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)

SWOG Cancer Research Network·interventional·Posted Apr 5, 2016·Updated Oct 20, 2022

In Brief

A clinical study evaluating Preventive Intervention, Quality-of-Life Assessment, and 1 other intervention for Febrile Neutropenia and 27 related conditions. Completed, enrolled 3,665 participants across 160 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFebrile 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
CountriesPuerto Rico, United States
CollaboratorsNational Cancer Institute (NCI), Patient-Centered Outcomes Research Institute

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartOct 7, 2016
Primary CompletionApr 30, 2021
Study CompletionAug 12, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 10.2 years ago

Interventions

Preventive Interventionother

Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies