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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 : August 31, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Southwest Oncology Group

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.

Condition or disease Intervention/treatment Phase
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 Other: Preventive Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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)
Study Start Date : October 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

Experimental: Clinic group 2 (clinic with no automated system)
Patients receive CSF based on clinical practice guidelines.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 ]
  7. Incidence of febrile neutropenia (clinical) graded according to the NCI Common Toxicity Criteria version 4.0 [ Time Frame: Within 6 months ]
  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; cancer may be metastatic or non-metastatic
  • Patients must be planning to receive one of the study-allowed regimens as their initial treatment for their current diagnosis
  • Patients must be registered prior to their first cycle of systemic therapy (chemotherapy, immunotherapy, biologic therapy, or combination regimens) for this diagnosis; if patient has had any prior systemic therapy for another malignancy, patient must not have had any systemic therapy in the 180 days just prior to registration
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728596


Contacts
Contact: Kimberly F. Kaberle 210-614-8808 ext 1022 kkaberle@swog.org
Contact: Dana Sparks, MAT 210-614-8808 ext 1004 dsparks@swog.org

  Show 151 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Scott Ramsey Southwest Oncology Group

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02728596     History of Changes
Other Study ID Numbers: 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 )
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Neutropenia
Fever
Febrile Neutropenia
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Agranulocytosis