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Trial record 1 of 1 for:    S1415CD
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S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) (TrACER)

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ClinicalTrials.gov Identifier: NCT02728596
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Change in FN-related HRQL (patient report) assessed using the Functional Assessment of Cancer Therapy -Febrile Neutropenia (FACT-N) [ Time Frame: Baseline to up to 14 days ]
    A linear mixed effects model will be fit to assess the effect of the intervention on HRQL. Component-level characteristics, patient-level clinical and demographic variables will be adjusted.
  • Change in patient knowledge of PP-CSF benefits (patient report) [ Time Frame: Baseline to up to 14 days (1 course) ]
    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, patient-level clinical and demographic variables will be adjusted.
  • Change in patient knowledge of PP-CSF indications (patient report) [ Time Frame: Baseline to up to 14 days ]
    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, patient-level clinical and demographic variables will be adjusted.
  • Change in patient knowledge of PP-CSF out-of-pocket costs (patient report) [ Time Frame: Baseline to up to 6 months ]
    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, patient-level clinical and demographic variables will be adjusted.
  • Change in patient knowledge of PP-CSF risks (patient report) [ Time Frame: Baseline to up to 14 days (1 course) ]
    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, patient-level clinical and demographic variables will be adjusted.
  • Incidence of febrile neutropenia (clinical) graded according to the National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 [ Time Frame: Within 14 days after the completion of first course of therapy ]
  • Incidence of febrile neutropenia (clinical) graded according to the NCI Common Toxicity Criteria version 4.0 [ Time Frame: Within 6 months ]
  • Overall survival (clinical) [ Time Frame: Time from date of registration to date of death due to any cause, assessed up to 12 months ]
    A Cox proportional hazards model will be used to model survival. Component-level characteristics, patient-level clinical and demographic variables will be adjusted. A separate analysis of cause-specific survival to address FN-related deaths will also be conducted.
  • Patient adherence to PP-CSF prescription (clinical and patient report) [ Time Frame: Within 14 days after the completion of first course of therapy ]
    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, patient-level clinical and demographic variables will be adjusted.
  • Prophylactic and FN-related antibiotic use (clinical) [ Time Frame: Within 30 days of therapy ]
    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
  • Proportion completing initial systemic therapy regimen: a) at planned duration and b) at planned dose intensity (clinical) [ Time Frame: Up to 12 months ]
    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.
  • Rate of CSF prescribing as primary prophylaxis (clinical) [ Time Frame: Time from initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy, assessed up to 12 months ]
    PP-CSF use is observed and reported. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use.
  • Rate of FN-related emergency department (ED) visits and hospitalizations (clinical) [ Time Frame: At 6 months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2016)
Cancer relapse (clinical) only to patients with local or regional disease treated with curative intent [ Time Frame: Time from registration to documented invasive local or regional recurrence, assessed up to 12 months ]
Analysis will be exploratory and comparative.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Febrile Neutropenia
  • Stage 0 Breast Cancer
  • Stage 0 Colorectal Cancer
  • Stage 0 Non-Small Cell Lung Cancer
  • Stage I Colorectal Cancer
  • Stage IA Breast Cancer
  • Stage IA Non-Small Cell Lung Carcinoma
  • Stage IB Breast Cancer
  • Stage IB Non-Small Cell Lung Carcinoma
  • Stage IIA Breast Cancer
  • Stage IIA Colorectal Cancer
  • Stage IIA Non-Small Cell Lung Carcinoma
  • Stage IIB Breast Cancer
  • Stage IIB Colorectal Cancer
  • Stage IIB Non-Small Cell Lung Carcinoma
  • Stage IIC Colorectal Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIA Colorectal Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIB Colorectal Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIC Breast Cancer
  • Stage IIIC Colorectal Cancer
  • Stage IV Breast Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer
Intervention  ICMJE
  • Other: Preventive Intervention
    Receive PP-CSF
    Other Names:
    • PREVENTATIVE
    • Prevention
    • Prevention Measures
    • Prophylaxis
    • PRYLX
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Other: Preventive Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Clinic group 2 (clinic with no automated system)
    Patients receive CSF based on clinical practice guidelines.
    Interventions:
    • Other: Preventive Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: 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.
    Interventions:
    • Other: Preventive Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Active Comparator: 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.
    Interventions:
    • Other: Preventive Intervention
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
3960
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia O'Kane, BS 210-614-8808 ext 1011 pokane@swog.org
Contact: Dana Sparks, MAT 210-614-8808 ext 1004 dsparks@swog.org
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728596
Other Study ID Numbers  ICMJE S1415CD
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Scott Ramsey Southwest Oncology Group
PRS Account Southwest Oncology Group
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP