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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Febrile Neutropenia
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 3665
- Locations
- 160
- Primary Endpoint
- Incidence of Febrile Neutropenia Among Intermediate Risk Participants
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This randomized clinical trial studies prophylactic colony stimulating factor management in patients with breast, colorectal or non-small cell lung cancer receiving chemotherapy and with risk of developing febrile neutropenia. Patients receiving chemotherapy may develop febrile neutropenia. Febrile neutropenia is a condition that involves fever and a low number of neutrophils (a type of white blood cell) in the blood. Febrile neutropenia increases the risk of infection. Colony stimulating factors are medications sometimes given to patients receiving chemotherapy to prevent febrile neutropenia. Colony stimulating factors are given to patients based on guidelines. Some clinics have an automated system that helps doctors decide when to prescribe them when there is a high risk of developing febrile neutropenia. Gathering information about the use of an automated system to prescribe prophylactic colony stimulating factor may help doctors use colony stimulating factor when it is needed.
Detailed Description
PRIMARY OBJECTIVES: I. To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among patients registered at intervention components versus usual care components. II. To compare the rate of febrile neutropenia (FN) among patients registered at intervention components versus usual care components. III. To compare the rate of FN among intermediate risk patients registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not). SECONDARY OBJECTIVES: I. To compare the rate of FN among low-risk patients registered at intervention components versus usual care components. II. To compare the FN-related health-related quality of life (HRQOL) among low-risk patients registered at intervention components versus usual care components. III. To compare patient adherence to PP-CSF prescribing among patients registered at intervention components versus usual care components. IV. To compare patient knowledge of the indications for, efficacy of, and side effects associated with PP-CSF between the initiation and conclusion of the first cycle of myelosuppressive systemic therapy among patients registered at intervention components versus usual care components. V. To compare the proportion of patients completing the initial systemic therapy regimen at planned duration and at planned dose intensity among patients registered at intervention components versus usual care components. VI. To compare antibiotic use both as prophylaxis and as treatment for FN among patients registered at intervention components versus usual care components. VII. To compare the rate of FN-related emergency department visits and hospitalizations among intermediate risk patients registered to Intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not). VIII. To compare the FN-related health-related quality of life (HRQOL) among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not). IX. To compare overall survival among intermediate risk patients registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk patients versus not). TERTIARY OBJECTIVES: I. To characterize and descriptively report the differences among cohort components and the intervention and usual care components. II. To evaluate the time to invasive recurrence in non-metastatic patients by component treatment assignment OUTLINE: Patients are randomized to 1 of 4 clinic groups. CLINIC GROUP 1 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN. CLINIC GROUP 2 (CLINIC WITH NO AUTOMATED SYSTEM): Patients receive CSF based on clinical practice guidelines. CLINIC GROUP 3 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high or moderate risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSFs not be used for drugs that have a low risk of FN. CLINIC GROUP 4 (CLINIC WITH AUTOMATED SYSTEM): Patients with a high risk of developing FN receive CSF based on the automated system recommendations. The automated system suggests that CSF not be used for drugs that have a moderate risk of FN. After completion of study treatment, patients are followed up for 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic
- •Patients must be registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage 9or disease setting).
- •Patients must not have had any systemic therapy (chemotherapy or combination regimens) in the 180 days just prior to registration. Prior biologic therapy, immunotherapy, tyrosine kinase inhibitors, and hormonal therapy are allowed.
- •Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current disease; myelosuppressive therapy must follow the standard regimen, although a dose reduction of up to 10% is permitted. This treatment may be neoadjuvant or adjuvant chemotherapy.
- •Patients must not be receiving or planning to receive concurrent radiation during systemic treatment.
- •Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim
- •Patients must be able to understand and provide information for the patient-completed study forms in either English or Spanish
- •Patients may have had a prior malignancy
- •Patients must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer treatments or investigational uses of CSF during their first 6 months after registration
- •Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
Time Frame: Within 6 months post registration
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.
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Time Frame: Baseline to up to 14 days
To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
Incidence of Febrile Neutropenia
Time Frame: Within 6 months post registration
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.
Secondary Outcomes
- Incidence of Febrile Neutropenia Among Low Risk Participants(Within 6 months of registration)
- FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants(Baseline to up to 14 days)
- Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)(Up to 12 months)
- Participant Adherence Rates to PP-CSF Prescription(Within 14 days after the completion of first course of therapy)
- Change in Participant Knowledge of PP-CSF Indications(Baseline to up to 14 days)
- Rate of FN-Related Emergency Department Visits and Hospitalizations(At 6 months)
- FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants(Baseline to up to 14 days)
- Prophylactic and FN-Related Antibiotic Use(Within 30 days of therapy)
- Overall Survival (OS)(Time from date of registration to date of death due to any cause, assessed up to 12 months)