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

Primary Purpose

Febrile Neutropenia, Stage 0 Breast Cancer, Stage 0 Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Preventive Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Febrile Neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
  • NEA Baptist Memorial Hospital
  • Contra Costa Regional Medical Center
  • Augusta University Medical Center
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Queen's Medical Center
  • Tripler Army Medical Center
  • Saint Alphonsus Cancer Care Center-Boise
  • Saint Luke's Mountain States Tumor Institute
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Illinois CancerCare-Bloomington
  • Illinois CancerCare-Canton
  • Illinois CancerCare-Carthage
  • Centralia Oncology Clinic
  • John H Stroger Jr Hospital of Cook County
  • Carle on Vermilion
  • Cancer Care Specialists of Illinois - Decatur
  • Carle Physician Group-Effingham
  • Crossroads Cancer Center
  • Illinois CancerCare-Eureka
  • Illinois CancerCare-Galesburg
  • Illinois CancerCare-Kewanee Clinic
  • Illinois CancerCare-Macomb
  • Carle Physician Group-Mattoon/Charleston
  • Illinois CancerCare-Ottawa Clinic
  • Illinois CancerCare-Pekin
  • Illinois CancerCare-Peoria
  • Illinois CancerCare-Peru
  • Illinois CancerCare-Princeton
  • Cancer Care Specialists of Illinois-Swansea
  • Carle Cancer Center
  • Oncology Associates at Mercy Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas-Kingman
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas - Newton
  • Menorah Medical Center
  • Cancer Center of Kansas - Parsons
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Wichita
  • Cancer Center of Kansas - Winfield
  • Louisiana State University Health Science Center
  • University Medical Center New Orleans
  • Louisiana State University Health Sciences Center Shreveport
  • Saint Joseph Mercy Hospital
  • Saint Joseph Mercy Brighton
  • Saint Joseph Mercy Canton
  • Saint Joseph Mercy Chelsea
  • Ascension Saint John Hospital
  • West Michigan Cancer Center
  • Saint Mary Mercy Hospital
  • William Beaumont Hospital-Royal Oak
  • William Beaumont Hospital - Troy
  • Saint John Macomb-Oakland Hospital
  • Sanford Joe Lueken Cancer Center
  • Essentia Health Saint Joseph's Medical Center
  • Essentia Health Cancer Center
  • Sanford Thief River Falls Medical Center
  • Sanford Cancer Center Worthington
  • Baptist Memorial Hospital and Cancer Center-Golden Triangle
  • Baptist Cancer Center-Grenada
  • Baptist Memorial Hospital and Cancer Center-Union County
  • Baptist Memorial Hospital and Cancer Center-Oxford
  • Baptist Memorial Hospital and Cancer Center-Desoto
  • Centerpoint Medical Center LLC
  • Research Medical Center
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • CHI Health Saint Francis
  • University of New Mexico Cancer Center
  • Presbyterian Kaseman Hospital
  • Presbyterian Rust Medical Center/Jorgensen Cancer Center
  • Christus Saint Vincent Regional Cancer Center
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • Novant Health Oncology Specialists-Kernersville
  • Novant Health Oncology Specialists-Mount Airy
  • Novant Health Oncology Specialists-Statesville
  • Novant Health Oncology Specialists-Davidson County
  • Novant Health Oncology Specialists-Wilkesboro
  • Novant Health Forsyth Medical Center
  • Novant Health Oncology Specialists
  • Sanford Bismarck Medical Center
  • Essentia Health Cancer Center-South University Clinic
  • Sanford Broadway Medical Center
  • Sanford Roger Maris Cancer Center
  • Dayton Physicians LLC-Miami Valley South
  • Adena Regional Medical Center
  • Dayton Physician LLC-Miami Valley Hospital North
  • Dayton Physicians LLC-Atrium
  • Dayton Physicians LLC-Wayne
  • Greater Dayton Cancer Center
  • Dayton Physicians LLC-Signal Point
  • Dayton Physicians LLC-Wilson
  • Dayton Physicians LLC-Upper Valley
  • Geisinger Medical Center
  • Geisinger Medical Center-Cancer Center Hazleton
  • Geisinger Medical Oncology-Lewisburg
  • Lewistown Hospital
  • Geisinger Cancer Services-Pottsville
  • Community Medical Center
  • Geisinger Medical Oncology-Selinsgrove
  • Geisinger Medical Group
  • Geisinger Wyoming Valley/Henry Cancer Center
  • Gibbs Cancer Center-Gaffney
  • Greenville Health System Cancer Institute-Butternut
  • Greenville Health System Cancer Institute-Faris
  • Greenville Memorial Hospital
  • Greenville Health System Cancer Institute-Eastside
  • Greenville Health System Cancer Institute-Greer
  • Gibbs Cancer Center-Pelham
  • Greenville Health System Cancer Institute-Seneca
  • Spartanburg Medical Center
  • Greenville Health System Cancer Institute-Spartanburg
  • MGC Hematology Oncology-Union
  • Sanford Cancer Center Oncology Clinic
  • Sanford USD Medical Center - Sioux Falls
  • Baptist Memorial Hospital and Cancer Center-Collierville
  • Integrity Oncology PLLC-Collierville
  • Baptist Memorial Hospital and Cancer Center-Memphis
  • Family Cancer Center-Memphis
  • Meharry Medical College
  • Logan Regional Hospital
  • Intermountain Medical Center
  • McKay-Dee Hospital Center
  • Dixie Medical Center Regional Cancer Center
  • MultiCare Auburn Medical Center
  • Swedish Cancer Institute-Edmonds
  • MultiCare Gig Harbor Medical Park
  • Swedish Cancer Institute-Issaquah
  • MultiCare Good Samaritan Hospital
  • Swedish Medical Center-Ballard Campus
  • Swedish Medical Center-First Hill
  • Swedish Medical Center-Cherry Hill
  • MultiCare Tacoma General Hospital
  • Marshfield Clinic-Chippewa Center
  • Marshfield Clinic Cancer Center at Sacred Heart
  • Marshfield Medical Center-EC Cancer Center
  • Marshfield Clinic - Ladysmith Center
  • Marshfield Medical Center-Marshfield
  • Marshfield Clinic-Minocqua Center
  • Marshfield Medical Center-Rice Lake
  • Marshfield Clinic Stevens Point Center
  • Marshfield Clinic-Wausau Center
  • Marshfield Clinic - Weston Center
  • Marshfield Clinic - Wisconsin Rapids Center
  • Doctors Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Clinic group 1 (clinics with existing automated system for CSF prescribing)

Clinic group 2 (clinics with no automated system for CSF prescribing)

Clinic group 3 (clinics with automated system for CSF prescribing)

Clinic group 4 (clinics with automated system for CSF prescribing)

Arm Description

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.

CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With CSF Prescribed as Primary Prophylaxis
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.
Incidence of Febrile Neutropenia
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.
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
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.

Secondary Outcome Measures

Incidence of Febrile Neutropenia Among Low Risk Participants
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.
FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants
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.
Participant Adherence Rates to PP-CSF Prescription
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.
Change in Participant Knowledge of PP-CSF Indications
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.
Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)
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.
Prophylactic and FN-Related Antibiotic Use
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
Rate of FN-Related Emergency Department Visits and Hospitalizations
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.
FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants
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.
Overall Survival (OS)
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.

Full Information

First Posted
March 30, 2016
Last Updated
September 23, 2022
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02728596
Brief Title
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
Acronym
TrACER
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2016 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
August 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic group 1 (clinics with existing automated system for CSF prescribing)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinic group 2 (clinics with no automated system for CSF prescribing)
Arm Type
Active Comparator
Arm Description
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
Arm Title
Clinic group 3 (clinics with automated system for CSF prescribing)
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinic group 4 (clinics with automated system for CSF prescribing)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Preventive Intervention
Other Intervention Name(s)
PREVENTATIVE, Prevention, Prevention Measures, Prophylaxis, PRYLX
Intervention Description
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Description
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.
Time Frame
Baseline to up to 14 days
Title
Incidence of Febrile Neutropenia
Description
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.
Time Frame
Within 6 months post registration
Title
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
Description
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.
Time Frame
Within 6 months post registration
Secondary Outcome Measure Information:
Title
Incidence of Febrile Neutropenia Among Low Risk Participants
Description
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.
Time Frame
Within 6 months of registration
Title
FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants
Description
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.
Time Frame
Baseline to up to 14 days
Title
Participant Adherence Rates to PP-CSF Prescription
Description
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.
Time Frame
Within 14 days after the completion of first course of therapy
Title
Change in Participant Knowledge of PP-CSF Indications
Description
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.
Time Frame
Baseline to up to 14 days
Title
Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)
Description
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.
Time Frame
Up to 12 months
Title
Prophylactic and FN-Related Antibiotic Use
Description
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
Time Frame
Within 30 days of therapy
Title
Rate of FN-Related Emergency Department Visits and Hospitalizations
Description
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.
Time Frame
At 6 months
Title
FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants
Description
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.
Time Frame
Baseline to up to 14 days
Title
Overall Survival (OS)
Description
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 Frame
Time from date of registration to date of death due to any cause, assessed up to 12 months
Other Pre-specified Outcome Measures:
Title
Time to Invasive Recurrence in Non-Metastatic Participants
Description
To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative.
Time Frame
Time from registration to documented invasive local or regional recurrence, assessed up to 12 months
Title
Differences Among Cohort Components and Intervention and Usual Care Components
Description
To characterize and descriptively report the differences among cohort components and the intervention and usual care components.
Time Frame
Up to 12 months post registration

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36279134
Citation
Ramsey SD, Bansal A, Sullivan SD, Lyman GH, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Kreizenbeck K, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Hershman DL. Effects of a Guideline-Informed Clinical Decision Support System Intervention to Improve Colony-Stimulating Factor Prescribing: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238191. doi: 10.1001/jamanetworkopen.2022.38191.
Results Reference
derived
PubMed Identifier
36228177
Citation
Hershman DL, Bansal A, Sullivan SD, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Ramsey SD. A Pragmatic Cluster-Randomized Trial of a Standing Order Entry Intervention for Colony-Stimulating Factor Use Among Patients at Intermediate Risk for Febrile Neutropenia. J Clin Oncol. 2023 Jan 20;41(3):590-598. doi: 10.1200/JCO.22.01258. Epub 2022 Oct 13.
Results Reference
derived
PubMed Identifier
35365139
Citation
Watabayashi KK, Bell-Brown A, Kreizenbeck K, Egan K, Lyman GH, Hershman DL, Arnold KB, Bansal A, Barlow WE, Sullivan SD, Ramsey SD. Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD. BMC Health Serv Res. 2022 Apr 1;22(1):432. doi: 10.1186/s12913-022-07835-4.
Results Reference
derived

Learn more about this trial

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

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