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NCT02728596 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2022-10-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With CSF Prescribed as Primary Prophylaxis

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outcome · POSTED

Incidence of Febrile Neutropenia

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outcome · POSTED

Incidence of Febrile Neutropenia Among Intermediate Risk Participants

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outcome · POSTED

Incidence of Febrile Neutropenia Among Low Risk Participants

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outcome · NOT POSTED

FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants

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outcome · NOT POSTED

Participant Adherence Rates to PP-CSF Prescription

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outcome · NOT POSTED

Change in Participant Knowledge of PP-CSF Indications

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outcome · NOT POSTED

Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)

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outcome · NOT POSTED

Prophylactic and FN-Related Antibiotic Use

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outcome · NOT POSTED

Rate of FN-Related Emergency Department Visits and Hospitalizations

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outcome · NOT POSTED

FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants

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outcome · NOT POSTED

Overall Survival (OS)

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outcome · NOT POSTED

Time to Invasive Recurrence in Non-Metastatic Participants

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outcome · NOT POSTED

Differences Among Cohort Components and Intervention and Usual Care Components

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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 * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Other: Preventive Intervention
    2. Other: Quality-of-Life Assessment
    3. Other: Questionnaire Administration
    label
    Clinic group 1 (clinics with existing automated system for CSF prescribing)
    type
    ACTIVE_COMPARATOR
  2. description
    CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
    intervention Names
    1. Other: Preventive Intervention
    2. Other: Quality-of-Life Assessment
    3. Other: Questionnaire Administration
    label
    Clinic group 2 (clinics with no automated system for CSF prescribing)
    type
    ACTIVE_COMPARATOR
  3. description
    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.
    intervention Names
    1. Other: Preventive Intervention
    2. Other: Quality-of-Life Assessment
    3. Other: Questionnaire Administration
    label
    Clinic group 3 (clinics with automated system for CSF prescribing)
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Other: Preventive Intervention
    2. Other: Quality-of-Life Assessment
    3. Other: Questionnaire Administration
    label
    Clinic group 4 (clinics with automated system for CSF prescribing)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Clinic group 1 (clinics with existing automated system for CSF prescribing)
    2. Clinic group 2 (clinics with no automated system for CSF prescribing)
    3. Clinic group 3 (clinics with automated system for CSF prescribing)
    4. Clinic group 4 (clinics with automated system for CSF prescribing)
    description
    Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
    name
    Preventive Intervention
    other Names
    1. PREVENTATIVE
    2. Prevention
    3. Prevention Measures
    4. Prophylaxis
    5. PRYLX
    type
    OTHER
  2. arm Group Labels
    1. Clinic group 1 (clinics with existing automated system for CSF prescribing)
    2. Clinic group 2 (clinics with no automated system for CSF prescribing)
    3. Clinic group 3 (clinics with automated system for CSF prescribing)
    4. Clinic group 4 (clinics with automated system for CSF prescribing)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  3. arm Group Labels
    1. Clinic group 1 (clinics with existing automated system for CSF prescribing)
    2. Clinic group 2 (clinics with no automated system for CSF prescribing)
    3. Clinic group 3 (clinics with automated system for CSF prescribing)
    4. Clinic group 4 (clinics with automated system for CSF prescribing)
    description
    Ancillary studies
    name
    Questionnaire Administration
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
HEALTH_SERVICES_RESEARCH
Enrollment
count
3665
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    To evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative.
    measure
    Time to Invasive Recurrence in Non-Metastatic Participants
    time Frame
    Time from registration to documented invasive local or regional recurrence, assessed up to 12 months
  2. description
    To characterize and descriptively report the differences among cohort components and the intervention and usual care components.
    measure
    Differences Among Cohort Components and Intervention and Usual Care Components
    time Frame
    Up to 12 months post registration
primary Outcomes
  1. description
    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.
    measure
    Percentage of Participants With CSF Prescribed as Primary Prophylaxis
    time Frame
    Baseline to up to 14 days
  2. description
    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.
    measure
    Incidence of Febrile Neutropenia
    time Frame
    Within 6 months post registration
  3. description
    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.
    measure
    Incidence of Febrile Neutropenia Among Intermediate Risk Participants
    time Frame
    Within 6 months post registration
secondary Outcomes
  1. description
    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.
    measure
    Incidence of Febrile Neutropenia Among Low Risk Participants
    time Frame
    Within 6 months of registration
  2. description
    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.
    measure
    FN-related Health-Related Quality of Life (HRQOL) Among Low Risk Participants
    time Frame
    Baseline to up to 14 days
  3. description
    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.
    measure
    Participant Adherence Rates to PP-CSF Prescription
    time Frame
    Within 14 days after the completion of first course of therapy
  4. description
    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.
    measure
    Change in Participant Knowledge of PP-CSF Indications
    time Frame
    Baseline to up to 14 days
  5. description
    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.
    measure
    Proportion Completing Initial Systemic Therapy Regimen: a) at Planned Duration and b) at Planned Dose Intensity (Clinical)
    time Frame
    Up to 12 months
  6. description
    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
    measure
    Prophylactic and FN-Related Antibiotic Use
    time Frame
    Within 30 days of therapy
  7. description
    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.
    measure
    Rate of FN-Related Emergency Department Visits and Hospitalizations
    time Frame
    At 6 months
  8. description
    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.
    measure
    FN-related Health-Related Quality of Life (HRQOL) Among Intermediate Risk Participants
    time Frame
    Baseline to up to 14 days
  9. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    Time from date of registration to date of death due to any cause, assessed up to 12 months
Full study description
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.
Source references
references
  1. citation
    Hershman DL, Bansal A, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Sullivan SD, Lyman GH, Ramsey SD. Intervention Nonadherence in the TrACER (S1415CD) Study: A Pragmatic Randomized Trial of a Standardized Order Entry for CSF Prescribing. JCO Oncol Pract. 2023 Dec;19(12):1160-1167. doi: 10.1200/OP.23.00219. Epub 2023 Oct 3.
    pmid
    37788414
    type
    DERIVED
  2. citation
    Lyman GH, Bansal A, Sullivan SD, Arnold KB, Barlow WE, Hershman DL, Lad TE, Ramsey SD. Impact of treatment experience on patient knowledge of colony-stimulating factors among patients receiving cancer chemotherapy: evidence from S1415CD-a large pragmatic trial. Support Care Cancer. 2023 Sep 28;31(10):598. doi: 10.1007/s00520-023-08056-z.
    pmid
    37770704
    type
    DERIVED
  3. citation
    Ramsey SD, Bansal A, Sullivan SD, Lyman GH, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Kreizenbeck K, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Hershman DL. Effects of a Guideline-Informed Clinical Decision Support System Intervention to Improve Colony-Stimulating Factor Prescribing: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238191. doi: 10.1001/jamanetworkopen.2022.38191.
    pmid
    36279134
    type
    DERIVED
  4. citation
    Hershman DL, Bansal A, Sullivan SD, Barlow WE, Arnold KB, Watabayashi K, Bell-Brown A, Le-Lindqwister NA, Dul CL, Brown-Glaberman UA, Behrens RJ, Vogel V, Alluri N, Ramsey SD. A Pragmatic Cluster-Randomized Trial of a Standing Order Entry Intervention for Colony-Stimulating Factor Use Among Patients at Intermediate Risk for Febrile Neutropenia. J Clin Oncol. 2023 Jan 20;41(3):590-598. doi: 10.1200/JCO.22.01258. Epub 2022 Oct 13.
    pmid
    36228177
    type
    DERIVED
  5. citation
    Watabayashi KK, Bell-Brown A, Kreizenbeck K, Egan K, Lyman GH, Hershman DL, Arnold KB, Bansal A, Barlow WE, Sullivan SD, Ramsey SD. Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD. BMC Health Serv Res. 2022 Apr 1;22(1):432. doi: 10.1186/s12913-022-07835-4.
    pmid
    35365139
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice