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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00264 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| S1415 | |||
| S1415CD | Other Identifier | SWOG | |
| SWOG-S1415CD | Other Identifier | DCP | |
| UG1CA189974 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preventive Intervention | Other | Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Within 6 months post registration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Invasive Recurrence in Non-Metastatic Participants | To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative. | Time from registration to documented invasive local or regional recurrence, assessed up to 12 months |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Ramsey | SWOG Cancer Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | 72401 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37788414 | Derived | 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. | |
| 37770704 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 13, 2019 |
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|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | Time from date of registration to date of death due to any cause, assessed up to 12 months |
| Differences Among Cohort Components and Intervention and Usual Care Components |
To characterize and descriptively report the differences among cohort components and the intervention and usual care components. |
| Up to 12 months post registration |
| NEA Baptist Memorial Hospital |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| Augusta University Medical Center | Augusta | Georgia | 30912 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Saint Luke's Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho | 83619 | United States |
| Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | 83642 | United States |
| Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho | 83686 | United States |
| Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Carle on Vermilion | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Carle Physician Group-Effingham | Effingham | Illinois | 62401 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | 61938 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | 62226 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | United States |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | United States |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| Saint Joseph Mercy Brighton | Brighton | Michigan | 48114 | United States |
| Saint Joseph Mercy Canton | Canton | Michigan | 48188 | United States |
| Saint Joseph Mercy Chelsea | Chelsea | Michigan | 48118 | United States |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Saint Mary Mercy Hospital | Livonia | Michigan | 48154 | United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital - Troy | Troy | Michigan | 48085 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Sanford Thief River Falls Medical Center | Thief River Falls | Minnesota | 56701 | United States |
| Sanford Cancer Center Worthington | Worthington | Minnesota | 56187 | United States |
| Baptist Memorial Hospital and Cancer Center-Golden Triangle | Columbus | Mississippi | 39705 | United States |
| Baptist Cancer Center-Grenada | Grenada | Mississippi | 38901 | United States |
| Baptist Memorial Hospital and Cancer Center-Union County | New Albany | Mississippi | 38652 | United States |
| Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi | 38655 | United States |
| Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi | 38671 | United States |
| Centerpoint Medical Center LLC | Independence | Missouri | 64057 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| CHI Health Saint Francis | Grand Island | Nebraska | 68803 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87102 | United States |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | 87110 | United States |
| Presbyterian Rust Medical Center/Jorgensen Cancer Center | Rio Rancho | New Mexico | 87124 | United States |
| Christus Saint Vincent Regional Cancer Center | Santa Fe | New Mexico | 87505 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Novant Health Oncology Specialists-Kernersville | Kernersville | North Carolina | 27284 | United States |
| Novant Health Oncology Specialists-Mount Airy | Mount Airy | North Carolina | 27030 | United States |
| Novant Health Oncology Specialists-Statesville | Statesville | North Carolina | 28625 | United States |
| Novant Health Oncology Specialists-Davidson County | Thomasville | North Carolina | 27360 | United States |
| Novant Health Oncology Specialists-Wilkesboro | Wilkesboro | North Carolina | 28659 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | United States |
| Essentia Health Cancer Center-South University Clinic | Fargo | North Dakota | 58103 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | United States |
| Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | 45459 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio | 45415 | United States |
| Dayton Physicians LLC-Atrium | Franklin | Ohio | 45005 | United States |
| Dayton Physicians LLC-Wayne | Greenville | Ohio | 45331 | United States |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | United States |
| Dayton Physicians LLC-Signal Point | Middletown | Ohio | 45042 | United States |
| Dayton Physicians LLC-Wilson | Sidney | Ohio | 45365 | United States |
| Dayton Physicians LLC-Upper Valley | Troy | Ohio | 45373 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Geisinger Medical Center-Cancer Center Hazleton | Hazleton | Pennsylvania | 18201 | United States |
| Geisinger Medical Oncology-Lewisburg | Lewisburg | Pennsylvania | 17837 | United States |
| Lewistown Hospital | Lewistown | Pennsylvania | 17044 | United States |
| Geisinger Cancer Services-Pottsville | Pottsville | Pennsylvania | 17901 | United States |
| Community Medical Center | Scranton | Pennsylvania | 18510 | United States |
| Geisinger Medical Oncology-Selinsgrove | Selinsgrove | Pennsylvania | 17870 | United States |
| Geisinger Medical Group | State College | Pennsylvania | 16801 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | 29605 | United States |
| Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | 29615 | United States |
| Greenville Health System Cancer Institute-Greer | Greer | South Carolina | 29650 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | 29307 | United States |
| MGC Hematology Oncology-Union | Union | South Carolina | 29379 | United States |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Baptist Memorial Hospital and Cancer Center-Collierville | Collierville | Tennessee | 38017 | United States |
| Integrity Oncology PLLC-Collierville | Collierville | Tennessee | 38017 | United States |
| Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee | 38120 | United States |
| Family Cancer Center-Memphis | Memphis | Tennessee | 38120 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| MultiCare Auburn Medical Center | Auburn | Washington | 98001 | United States |
| Swedish Cancer Institute-Edmonds | Edmonds | Washington | 98026 | United States |
| MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | 98335 | United States |
| Swedish Cancer Institute-Issaquah | Issaquah | Washington | 98029 | United States |
| MultiCare Good Samaritan Hospital | Puyallup | Washington | 98372 | United States |
| Swedish Medical Center-Ballard Campus | Seattle | Washington | 98107 | United States |
| Swedish Medical Center-First Hill | Seattle | Washington | 98122-4307 | United States |
| Swedish Medical Center-Cherry Hill | Seattle | Washington | 98122-5711 | United States |
| MultiCare Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin | 54729 | United States |
| Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin | 54701 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | United States |
| Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin | 54848 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | 54482 | United States |
| Marshfield Clinic-Wausau Center | Wausau | Wisconsin | 54401 | United States |
| Marshfield Clinic - Weston Center | Weston | Wisconsin | 54476 | United States |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Doctors Cancer Center | Manati | 00674 | Puerto Rico |
| 36279134 | Derived | 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. |
| 36228177 | Derived | 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. |
| 35365139 | Derived | 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. |
| FG001 | Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines. 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 |
| FG002 | Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN. 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 |
| FG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. 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 |
| Treatment Completed |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN. |
| BG001 | Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines. |
| BG002 | Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN. |
| BG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Febrile Neutropenia Risk Level | Febrile Neutropenia (FN) Risk Levels are defined as:
| Count of Participants | Participants |
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| Cancer Type | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There was one participant in Arm 4, that was deemed as having an unavailable outcome and was excluded from this analysis population. Leaving Arm 4 with 972 analyzable participants rather than 973. | Posted | Number | percentage of participants | Baseline to up to 14 days |
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| Primary | 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. | There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants. | Posted | Number | percentage of participants | Within 6 months post registration |
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| Primary | 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. | The analysis population includes only participants that are classified as having intermediate risk of FN. Seven participants were deemed as having an unavailable outcome and were excluded from the analysis population. | Posted | Number | percentage of participants | Within 6 months post registration |
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| Secondary | 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. | The analysis population includes only participants deemed 'low-risk' within each of the clinic groups. | Posted | Number | percentage of participants | Within 6 months of registration |
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| Secondary | 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. | Not Posted | Baseline to up to 14 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Within 14 days after the completion of first course of therapy | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline to up to 14 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Within 30 days of therapy | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | At 6 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Baseline to up to 14 days | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Time from date of registration to date of death due to any cause, assessed up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Time to Invasive Recurrence in Non-Metastatic Participants | To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative. | Not Posted | Time from registration to documented invasive local or regional recurrence, assessed up to 12 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Differences Among Cohort Components and Intervention and Usual Care Components | To characterize and descriptively report the differences among cohort components and the intervention and usual care components. | Not Posted | Up to 12 months post registration | Participants |
Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN. | 44 | 707 | 3 | 456 | 146 | 456 |
| EG001 | Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines. | 42 | 644 | 0 | 350 | 123 | 350 |
| EG002 | Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN. | 123 | 1,281 | 0 | 694 | 243 | 694 |
| EG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. | 68 | 973 | 1 | 448 | 171 | 448 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SWOG Statistician | SWOG Statistics and Data Management Center | 2066674623 | karnold@fredhutch.org |
| Jul 21, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D000071960 | Breast Carcinoma In Situ |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Intermediate |
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| High |
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| Colorectal |
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| NSCLC |
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| Intermediate Risk Group |
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| High Risk Group |
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| All FN Risk Groups |
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PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined). |
| Regression, Logistic |
Adjusted for age, sex, and cancer type. |
| 0.74 |
| Odds Ratio (OR) |
| 1.18 |
| 2-Sided |
| 95 |
| 0.44 |
| 3.20 |
| Superiority |
| PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3). | Regression, Logistic | Adjusted for age, sex, and cancer type. | 0.17 | Odds Ratio (OR) | 2.23 | 2-Sided | 95 | 0.70 | 7.08 | Superiority |
| PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4). | Regression, Logistic | Adjusted for age, sex, and cancer type. | 0.094 | Odds Ratio (OR) | 0.36 | 2-Sided | 95 | 0.11 | 1.19 | Superiority |
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. |
| OG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. |
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| OG002 | Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN. |
| OG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. |
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| OG002 | Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN. 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 |
| OG003 | Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing) | CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN. 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 |
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