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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,665
- 试验地点
- 160
- 主要终点
- Incidence of Febrile Neutropenia Among Intermediate Risk Participants
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Preventive Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Preventive Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Preventive Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Preventive Intervention (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)