Febrile NeutropeniaTrACERNCT02728596
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
A study testing Preventive Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Febrile Neutropenia and Stage 0 Breast Cancer, run by SWOG Cancer Research Network at 160 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia, Stage 0 Breast Cancer, Stage 0 Colorectal Cancer
- What is being tested?
- Preventive Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,665 participants
- Where
- 160 sitesin 2 countries
- Study dates
- 7 Oct 2016to 12 Aug 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
160 sites in 2 countries.
160 sites in 2 countries
United States159 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Augusta University Medical Center
Augusta, Georgia, 30912
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Billings Clinic Cancer Center
Billings, Montana, 59101
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Bozeman Deaconess Hospital
Bozeman, Montana, 59715
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Saint Joseph Mercy Brighton
Brighton, Michigan, 48114
Illinois CancerCare-Canton
Canton, Illinois, 61520
Saint Joseph Mercy Canton
Canton, Michigan, 48188
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
Centralia Oncology Clinic
Centralia, Illinois, 62801
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720
Saint Joseph Mercy Chelsea
Chelsea, Michigan, 48118
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
Integrity Oncology PLLC-Collierville
Collierville, Tennessee, 38017
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, 39705
Carle on Vermilion
Danville, Illinois, 61832
Geisinger Medical Center
Danville, Pennsylvania, 17822
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio, 45415
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309
Ascension Saint John Hospital
Detroit, Michigan, 48236
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Crossroads Cancer Center
Effingham, Illinois, 62401
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, 83619
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335
CHI Health Saint Francis
Grand Island, Nebraska, 68803
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
Baptist Cancer Center-Grenada
Grenada, Mississippi, 38901
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
Queen's Medical Center
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Cancer Center of Kansas-Independence
Independence, Kansas, 67301
Centerpoint Medical Center LLC
Independence, Missouri, 64057
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Research Medical Center
Kansas City, Missouri, 64132
Novant Health Oncology Specialists-Kernersville
Kernersville, North Carolina, 27284
Greater Dayton Cancer Center
Kettering, Ohio, 45409
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin, 54848
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905
Saint Mary Mercy Hospital
Livonia, Michigan, 48154
Logan Regional Hospital
Logan, Utah, 84321
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
Family Cancer Center-Memphis
Memphis, Tennessee, 38120
Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho, 83642
Dayton Physicians LLC-Signal Point
Middletown, Ohio, 45042
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548
Novant Health Oncology Specialists-Mount Airy
Mount Airy, North Carolina, 27030
Intermountain Medical Center
Murray, Utah, 84107
Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho, 83686
Meharry Medical College
Nashville, Tennessee, 37208
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, 38652
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
University Medical Center New Orleans
New Orleans, Louisiana, 70112
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Cancer Center of Kansas - Newton
Newton, Kansas, 67114
McKay-Dee Hospital Center
Ogden, Utah, 84403
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Menorah Medical Center
Overland Park, Kansas, 66209
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, 38655
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Illinois CancerCare-Peru
Peru, Illinois, 61354
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, 87124
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Cancer Center of Kansas - Salina
Salina, Kansas, 67401
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Community Medical Center
Scranton, Pennsylvania, 18510
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, 17870
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672
Louisiana State University Health Sciences Center Shreveport
Shreveport, Louisiana, 71103
Dayton Physicians LLC-Wilson
Sidney, Ohio, 45365
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307
Mercy Hospital Springfield
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770
Geisinger Medical Group
State College, Pennsylvania, 16801
Novant Health Oncology Specialists-Statesville
Statesville, North Carolina, 28625
Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin, 54482
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, 62226
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Novant Health Oncology Specialists-Davidson County
Thomasville, North Carolina, 27360
William Beaumont Hospital - Troy
Troy, Michigan, 48085
Dayton Physicians LLC-Upper Valley
Troy, Ohio, 45373
Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho, 83301
MGC Hematology Oncology-Union
Union, South Carolina, 29379
Carle Cancer Center
Urbana, Illinois, 61801
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
Novant Health Oncology Specialists-Wilkesboro
Wilkesboro, North Carolina, 28659
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187
About this study
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)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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:
- 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
- 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
- Being tested
- Preventive Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Febrile Neutropenia, Breast Carcinoma In Situ, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive InterventionOther
Also called PREVENTATIVE, Prevention, Prevention Measures, Prophylaxis
Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Clinic group 1 (clinics with existing automated system for CSF prescribing) | Active comparator | 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. Receives: Other: Preventive Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Clinic group 2 (clinics with no automated system for CSF prescribing) | Active comparator | CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines. Receives: Other: Preventive Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Clinic group 3 (clinics with automated system for CSF prescribing) | Experimental | 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. Receives: Other: Preventive Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Clinic group 4 (clinics with automated system for CSF prescribing) | Experimental | 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. Receives: Other: Preventive Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 14 days
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.
Measured: Within 6 months post registration
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.
Measured: Within 6 months post registration
Secondary outcomes (9)
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.
Measured: Within 6 months of registration
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.
Measured: Baseline to up to 14 days
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.
Measured: Within 14 days after the completion of first course of therapy
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.
Measured: Baseline to up to 14 days
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.
Measured: Up to 12 months
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
Measured: Within 30 days of therapy
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.
Measured: At 6 months
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.
Measured: Baseline to up to 14 days
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.
Measured: Time from date of registration to date of death due to any cause, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start7 Oct 2016
- Primary completion30 Apr 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,665 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Scott Ramsey, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728596
- Sponsor's protocol ID
- S1415CD
- Other IDs
- NCI-2016-00264, S1415, S1415CD, SWOG-S1415CD, UG1CA189974
- Acronym
- TrACER
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2016
- Last updated
- 20 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37788414Lyman 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.
PubMed 37770704Ramsey 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.
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