S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
NCT ID: NCT02728596
Last Updated: 2022-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
3665 participants
INTERVENTIONAL
2016-10-07
2021-08-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Preventive Intervention
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Patient-Centered Outcomes Research Institute
OTHER
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Scott Ramsey
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, United States
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Carle on Vermilion
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Saint Joseph Mercy Brighton
Brighton, Michigan, United States
Saint Joseph Mercy Canton
Canton, Michigan, United States
Saint Joseph Mercy Chelsea
Chelsea, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy
Troy, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
CHI Health Saint Francis
Grand Island, Nebraska, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Novant Health Oncology Specialists-Kernersville
Kernersville, North Carolina, United States
Novant Health Oncology Specialists-Mount Airy
Mount Airy, North Carolina, United States
Novant Health Oncology Specialists-Statesville
Statesville, North Carolina, United States
Novant Health Oncology Specialists-Davidson County
Thomasville, North Carolina, United States
Novant Health Oncology Specialists-Wilkesboro
Wilkesboro, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Dayton Physicians LLC-Signal Point
Middletown, Ohio, United States
Dayton Physicians LLC-Wilson
Sidney, Ohio, United States
Dayton Physicians LLC-Upper Valley
Troy, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union
Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Integrity Oncology PLLC-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Family Cancer Center-Memphis
Memphis, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Logan Regional Hospital
Logan, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Doctors Cancer Center
Manatí, , Puerto Rico
Countries
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References
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Hershman DL, Bansal A, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Sullivan SD, Lyman GH, Ramsey SD. Intervention Nonadherence in the TrACER (S1415CD) Study: A Pragmatic Randomized Trial of a Standardized Order Entry for CSF Prescribing. JCO Oncol Pract. 2023 Dec;19(12):1160-1167. doi: 10.1200/OP.23.00219. Epub 2023 Oct 3.
Lyman GH, Bansal A, Sullivan SD, Arnold KB, Barlow WE, Hershman DL, Lad TE, Ramsey SD. Impact of treatment experience on patient knowledge of colony-stimulating factors among patients receiving cancer chemotherapy: evidence from S1415CD-a large pragmatic trial. Support Care Cancer. 2023 Sep 28;31(10):598. doi: 10.1007/s00520-023-08056-z.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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NCI-2016-00264
Identifier Type: REGISTRY
Identifier Source: secondary_id
S1415
Identifier Type: -
Identifier Source: secondary_id
S1415CD
Identifier Type: OTHER
Identifier Source: secondary_id
SWOG-S1415CD
Identifier Type: OTHER
Identifier Source: secondary_id
S1415CD
Identifier Type: -
Identifier Source: org_study_id
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