S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
NCT02728596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3665
Last updated 2022-10-20
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.
Conditions
- Febrile 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
Interventions
- OTHER
-
Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
SWOG Cancer Research Network
lead NETWORK
Principal Investigators
-
Scott Ramsey · SWOG Cancer Research Network
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-07
- Primary Completion
- 2021-04-30
- Completion
- 2021-08-12
Countries
- United States
- Puerto Rico
Study Locations
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