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

September 23, 2022 updated by: Southwest Oncology Group

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3665

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Manati, Puerto Rico, 00674
        • Doctors Cancer Center
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Baptist Memorial Hospital
      • Jonesboro, Arkansas, United States, 72401
        • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, United States, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Mountain States Tumor Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Danville, Illinois, United States, 61832
        • Carle on Vermilion
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Swansea, Illinois, United States, 62226
        • Cancer Care Specialists of Illinois-Swansea
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, United States, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Liberal, Kansas, United States, 67905
        • Cancer Center of Kansas-Liberal
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Wichita
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center Shreveport
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital
      • Brighton, Michigan, United States, 48114
        • Saint Joseph Mercy Brighton
      • Canton, Michigan, United States, 48188
        • Saint Joseph Mercy Canton
      • Chelsea, Michigan, United States, 48118
        • Saint Joseph Mercy Chelsea
      • Detroit, Michigan, United States, 48236
        • Ascension Saint John Hospital
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Troy, Michigan, United States, 48085
        • William Beaumont Hospital - Troy
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
        • Sanford Joe Lueken Cancer Center
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health Saint Joseph's Medical Center
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Thief River Falls, Minnesota, United States, 56701
        • Sanford Thief River Falls Medical Center
      • Worthington, Minnesota, United States, 56187
        • Sanford Cancer Center Worthington
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
      • Grenada, Mississippi, United States, 38901
        • Baptist Cancer Center-Grenada
      • New Albany, Mississippi, United States, 38652
        • Baptist Memorial Hospital and Cancer Center-Union County
      • Oxford, Mississippi, United States, 38655
        • Baptist Memorial Hospital and Cancer Center-Oxford
      • Southhaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center LLC
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • Springfield, Missouri, United States, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Hospital
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • CHI Health Saint Francis
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Kaseman Hospital
      • Rio Rancho, New Mexico, United States, 87124
        • Presbyterian Rust Medical Center/Jorgensen Cancer Center
      • Santa Fe, New Mexico, United States, 87505
        • Christus Saint Vincent Regional Cancer Center
    • New York
      • New York, New York, United States, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Kernersville, North Carolina, United States, 27284
        • Novant Health Oncology Specialists-Kernersville
      • Mount Airy, North Carolina, United States, 27030
        • Novant Health Oncology Specialists-Mount Airy
      • Statesville, North Carolina, United States, 28625
        • Novant Health Oncology Specialists-Statesville
      • Thomasville, North Carolina, United States, 27360
        • Novant Health Oncology Specialists-Davidson County
      • Wilkesboro, North Carolina, United States, 28659
        • Novant Health Oncology Specialists-Wilkesboro
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, United States, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Cancer Center-South University Clinic
      • Fargo, North Dakota, United States, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Dayton, Ohio, United States, 45415
        • Dayton Physician LLC-Miami Valley Hospital North
      • Franklin, Ohio, United States, 45005
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Dayton Physicians LLC-Wayne
      • Kettering, Ohio, United States, 45409
        • Greater Dayton Cancer Center
      • Middletown, Ohio, United States, 45042
        • Dayton Physicians LLC-Signal Point
      • Sidney, Ohio, United States, 45365
        • Dayton Physicians LLC-Wilson
      • Troy, Ohio, United States, 45373
        • Dayton Physicians LLC-Upper Valley
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • Selinsgrove, Pennsylvania, United States, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, United States, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greer, South Carolina, United States, 29651
        • Gibbs Cancer Center-Pelham
      • Greer, South Carolina, United States, 29650
        • Greenville Health System Cancer Institute-Greer
      • Seneca, South Carolina, United States, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, United States, 29307
        • Greenville Health System Cancer Institute-Spartanburg
      • Union, South Carolina, United States, 29379
        • MGC Hematology Oncology-Union
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Collierville, Tennessee, United States, 38017
        • Integrity Oncology PLLC-Collierville
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Memphis, Tennessee, United States, 38120
        • Family Cancer Center-Memphis
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
    • Utah
      • Logan, Utah, United States, 84321
        • Logan Regional Hospital
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Saint George, Utah, United States, 84770
        • Dixie Medical Center Regional Cancer Center
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Edmonds, Washington, United States, 98026
        • Swedish Cancer Institute-Edmonds
      • Gig Harbor, Washington, United States, 98335
        • MultiCare Gig Harbor Medical Park
      • Issaquah, Washington, United States, 98029
        • Swedish Cancer Institute-Issaquah
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98122-5711
        • Swedish Medical Center-Cherry Hill
      • Tacoma, Washington, United States, 98405
        • MultiCare Tacoma General Hospital
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Ladysmith, Wisconsin, United States, 54848
        • Marshfield Clinic - Ladysmith Center
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Rice Lake, Wisconsin, United States, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, United States, 54482
        • Marshfield Clinic Stevens Point Center
      • Wausau, Wisconsin, United States, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Clinic group 1 (clinics with existing automated system for CSF prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Other Names:
  • Prevention
  • PREVENTATIVE
  • Prevention Measures
  • PRYLX
  • Prophylaxis
ACTIVE_COMPARATOR: Clinic group 2 (clinics with no automated system for CSF prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Other Names:
  • Prevention
  • PREVENTATIVE
  • Prevention Measures
  • PRYLX
  • Prophylaxis
EXPERIMENTAL: Clinic group 3 (clinics with automated system for CSF prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Other Names:
  • Prevention
  • PREVENTATIVE
  • Prevention Measures
  • PRYLX
  • Prophylaxis
EXPERIMENTAL: Clinic group 4 (clinics with automated system for CSF prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Other Names:
  • Prevention
  • PREVENTATIVE
  • Prevention Measures
  • PRYLX
  • Prophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Time Frame: Baseline to up to 14 days
To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
Baseline to up to 14 days
Incidence of Febrile Neutropenia
Time Frame: Within 6 months post registration
To compare the rate of febrile neutropenia (FN) among participants, at any risk level, registered at intervention components versus usual care components. Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) < 1000/µL and a single temperature of > 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Within 6 months post registration
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
Time Frame: Within 6 months post registration
To compare the rate of FN among intermediate risk participants registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) < 1000/µL and a single temperature of > 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Within 6 months post registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Febrile Neutropenia Among Low Risk Participants
Time Frame: Within 6 months of registration
To compare the rate of FN among low-risk participants registered at intervention components versus usual care components. Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) < 1000/µL and a single temperature of > 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Within 6 months of registration
FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants
Time Frame: Baseline to up to 14 days
To compare the FN-related health-related quality of life (HRQOL) among low-risk participants registered at intervention components versus usual care components. Assessed using the Functional Assessment of Cancer Therapy - Febrile Neutropenia (Version 4) (FACT-N). Includes FACT general cancer score and FN-related score. A linear mixed effects model will be fit to assess the effect of the intervention on HRQOL. Component-level characteristics, patient-level clinical and demographic variables will be adjusted.
Baseline to up to 14 days
Participant Adherence Rates to PP-CSF Prescription
Time Frame: Within 14 days after the completion of first course of therapy
To compare adherence to PP-CSF prescribing among participants registered at intervention components versus usual care components. Participant adherence rates are obtained from the proportion receiving PP-CSF among those for whom PP-CSF was ordered by the physician. The primary adherence measure will be obtained from the participant's chart; secondary adherence will be measured via self-report on the Follow-Up Participant Survey. For the home and clinic settings, separate mixed effects logistic models will be used to assess the effect of the intervention on adherence to PP-CSF orders, treating adherence after the start of the study. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Within 14 days after the completion of first course of therapy
Change in Participant Knowledge of PP-CSF Indications
Time Frame: Baseline to up to 14 days
To compare participant 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 participants registered at intervention components versus usual care components. Linear mixed effects model with a time variable and an interaction between randomized group and time will be used to analyze change in the patient knowledge score. Random effects will be used to accommodate both the correlation among measures from the same patient as well as the correlation among patients from the same component. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Baseline to up to 14 days
Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)
Time Frame: Up to 12 months
To compare the proportion of participants completing the initial systemic therapy regimen at planned duration and at planned dose intensity among participants registered at intervention components versus usual care components.Two separate mixed effects logistic models will be used to assess the effect of the intervention on completion of the initial systemic therapy regimen (i) at planned duration and (ii) at planned dose intensity. Component-level characteristics, patient-level clinical and demographic variables will be adjusted.
Up to 12 months
Prophylactic and FN-Related Antibiotic Use
Time Frame: Within 30 days of therapy
To compare antibiotic use both as prophylaxis and as treatment for FN among participants registered at intervention components versus usual care components. Prophylactic and FN-related antibiotic use will be measured as total number of antibiotic agents used and duration of antibiotic use. A linear mixed effects model will be fit to assess the effect of the intervention on duration of antibiotics use with number of days. Mixed effects Poisson models will be used to assess the effect of the intervention on total number of antibiotics agents used. Three separate models will be fit, with the following outcomes: (i) the number of times antibiotics were used as prophylaxis, (ii) the number of times antibiotics were used as treatment for FN, and (iii) t
Within 30 days of therapy
Rate of FN-Related Emergency Department Visits and Hospitalizations
Time Frame: At 6 months
To compare the rate of FN-related emergency department (ED) visits and hospitalizations among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). FN-related ED visits and hospitalizations are defined as admission to ED or hospital with documentation of fever and decreased ANC. A mixed effects Poisson model will be used to assess the effect of the intervention on FN-related ED visits and hospitalizations. Robust variance estimation will be used to relax the strong assumptions about the variance made by Poisson regression. If a large number of zero counts is observed, then zero-inflated Poisson regression will be used.
At 6 months
FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants
Time Frame: Baseline to up to 14 days
To compare the FN-related health-related quality of life (HRQOL) among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Assessed using the Functional Assessment of Cancer Therapy - Febrile Neutropenia (Version 4) (FACT-N). Includes FACT general cancer score and FN-related score. A linear mixed effects model will be fit to assess the effect of the intervention on HRQOL. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Baseline to up to 14 days
Overall Survival (OS)
Time Frame: Time from date of registration to date of death due to any cause, assessed up to 12 months
To compare overall survival among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). A Cox proportional hazards model will be used to model survival. Component-level characteristics, participant-level clinical and demographic variables will be adjusted. A separate analysis of cause-specific survival to address FN-related deaths will also be conducted.
Time from date of registration to date of death due to any cause, assessed up to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Invasive Recurrence in Non-Metastatic Participants
Time Frame: Time from registration to documented invasive local or regional recurrence, assessed up to 12 months
To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative.
Time from registration to documented invasive local or regional recurrence, assessed up to 12 months
Differences Among Cohort Components and Intervention and Usual Care Components
Time Frame: Up to 12 months post registration
To characterize and descriptively report the differences among cohort components and the intervention and usual care components.
Up to 12 months post registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

Patient-Centered Outcomes Research Institute
National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Scott Ramsey, Southwest Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2016

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

August 12, 2021

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1415CD (OTHER: SWOG)
  • UG1CA189974 (U.S. NIH Grant/Contract)
  • NCI-2016-00264 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • S1415
  • SWOG-S1415CD (OTHER: DCP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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