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Breast Carcinoma In Situ

Febrile Neutropenia

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Neoplasms by Histologic Type

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Granulocytopenia

CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.

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

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.

CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.

Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN

Preventive Intervention

Quality-of-Life Assessment

Questionnaire Administration

Scott Ramsey

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.

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

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)

To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative.

To characterize and descriptively report the differences among cohort components and the intervention and usual care components.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

National Cancer Institute (NCI)

Patient-Centered Outcomes Research Institute

SWOG Cancer Research Network

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.

Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)

Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)

Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)

Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Intermediate

High

Febrile Neutropenia (FN) Risk Levels are defined as:

* Low: \< 10% risk of FN
* Intermediate: 10-20% of FN
* High: \> 20% risk of FN

Febrile Neutropenia Risk Level

Breast

Colorectal

NSCLC

Cancer Type

SWOG Statistician

PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).

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).

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).

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).

Low Risk Group

Intermediate Risk Group

High Risk Group

All FN Risk Groups

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.

Percentage of Participants With CSF Prescribed as Primary Prophylaxis

FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).

FN incidence rate 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).

FN incidence rate 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).

FN incidence rate 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).

There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants.

Incidence of Febrile Neutropenia

This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.

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.

Incidence of Febrile Neutropenia Among Intermediate Risk Participants

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

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

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

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

The analysis population includes only participants deemed 'low-risk' within each of the clinic groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)	NCT02728596	Febrile Neutrop... Stage 0 Breast ... Stage 0 Colorec... Stage 0 Non-Sma... Stage I Colorec... Stage IA Breast... Stage IA Non-Sm... Stage IB Breast... Stage IB Non-Sm... Stage IIA Breas... Stage IIA Color... Stage IIA Non-S... Stage IIB Breas... Stage IIB Color... Stage IIB Non-S... Stage IIC Color... Stage IIIA Brea... Stage IIIA Colo... Stage IIIA Non-... Stage IIIB Brea... Stage IIIB Colo... Stage IIIB Non-... Stage IIIC Brea... Stage IIIC Colo... Stage IV Breast... Stage IV Non-Sm... Stage IVA Color... Stage IVB Color...	Preventive Inte... Quality-of-Life... Questionnaire A...	18 Years -	SWOG Cancer Research Network
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)	NCT02728596	Febrile Neutrop... Stage 0 Breast ... Stage 0 Colorec... Stage 0 Non-Sma... Stage I Colorec... Stage IA Breast... Stage IA Non-Sm... Stage IB Breast... Stage IB Non-Sm... Stage IIA Breas... Stage IIA Color... Stage IIA Non-S... Stage IIB Breas... Stage IIB Color... Stage IIB Non-S... Stage IIC Color... Stage IIIA Brea... Stage IIIA Colo... Stage IIIA Non-... Stage IIIB Brea... Stage IIIB Colo... Stage IIIB Non-... Stage IIIC Brea... Stage IIIC Colo... Stage IV Breast... Stage IV Non-Sm... Stage IVA Color... Stage IVB Color...	Preventive Inte... Quality-of-Life... Questionnaire A...	18 Years -	SWOG Cancer Research Network

Spots Global Cancer Trial Database for stage 0 colorectal cancer