Last updated on December 2018

S1415CD Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02728596

Find a site near you

Start Over

Saint Joseph Mercy Hospital

Ann Arbor, MI United States
  Connect »

Gibbs Cancer Center-Gaffney

Gaffney, SC United States
  Connect »

Marshfield Clinic-Chippewa Center

Chippewa Falls, WI United States
  Connect »

Spartanburg Medical Center

Spartanburg, SC United States
  Connect »

Presbyterian Kaseman Hospital

Albuquerque, NM United States
  Connect »

Carle Cancer Center

Urbana, IL United States
  Connect »

Adena Regional Medical Center

Chillicothe, OH United States
  Connect »

Meharry Medical College

Nashville, TN United States
  Connect »

Illinois CancerCare-Bloomington

Bloomington, IL United States
  Connect »

Queen's Medical Center

Honolulu, HI United States
  Connect »

Tripler Army Medical Center

Honolulu, HI United States
  Connect »

Illinois CancerCare-Carthage

Carthage, IL United States
  Connect »

Centralia Oncology Clinic

Centralia, IL United States
  Connect »

Carle on Vermilion

Danville, IL United States
  Connect »

Crossroads Cancer Center

Effingham, IL United States
  Connect »

Illinois CancerCare-Galesburg

Galesburg, IL United States
  Connect »

Illinois CancerCare-Princeton

Princeton, IL United States
  Connect »

West Michigan Cancer Center

Kalamazoo, MI United States
  Connect »

Saint Mary Mercy Hospital

Livonia, MI United States
  Connect »

Research Medical Center

Kansas City, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

Mercy Hospital Springfield

Springfield, MO United States
  Connect »

CoxHealth South Hospital

Springfield, MO United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

CHI Health Saint Francis

Grand Island, NE United States
  Connect »

Novant Health Forsyth Medical Center

Winston-Salem, NC United States
  Connect »

Novant Health Oncology Specialists

Winston-Salem, NC United States
  Connect »

Dayton Physicians LLC-Atrium

Franklin, OH United States
  Connect »

Dayton Physicians LLC-Wayne

Greenville, OH United States
  Connect »

Geisinger Medical Center

Danville, PA United States
  Connect »

Community Medical Center

Scranton, PA United States
  Connect »

Geisinger Medical Group

State College, PA United States
  Connect »

Greenville Memorial Hospital

Greenville, SC United States
  Connect »

Marshfield Clinic

Marshfield, WI United States
  Connect »

Saint Joseph Mercy Brighton

Brighton, MI United States
  Connect »

Saint Joseph Mercy Canton

Canton, MI United States
  Connect »

Saint Joseph Mercy Chelsea

Chelsea, MI United States
  Connect »

Lewistown Hospital

Lewistown, PA United States
  Connect »

NEA Baptist Memorial Hospital

Jonesboro, AR United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.