SWOG clinical trial number
S1415CD

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 Prophylaxis for Patients Receiving Chemotherapy with Intermediate Risk for Febrile Neutropenia - Trial Assessing CSF Prescribing, Effectiveness and Risk (TrACER)

Closed
Phase
Accrual
93%
Abbreviated Title
Trial Assessing CSF Prescribing, Effectiveness and Risk (TRACER)
Status Notes
This study was permanently closed to accrual effective 4/15/20.
Activated
10/07/2016
Participants
Limited: Institutions Listed on the Title Page

Eligibility Criteria Expand/Collapse

Requirements to become a participating component:
*Site must submit application and be approved by the Study Chair in order to participate.

Patients must have a current diagnosis of breast cancer, NSCL cancer, or colorectal cancer; 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 registered prior to or on the same day as their first cycle of chemotherapy for their current disease and stage (or disease setting). Patients must not have had any systemic therapy (chemo or combination regimens) in the last 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 E Coli derived proteins, filgrastim, pegfilgrastim. or tbo-filgrastim. Patients must be >/= 18 years of age, must be able to understand and provide information for the patient-completed forms in either English or Spanish; patients may have had a prior malignancy and must not be participating or plan to participate in other clinical trials that involve investigational systemic cancer or investigational uses of CSF during their first 6 months after registration.

Publication Information Expand/Collapse

2023

A Pragmatic Cluster-Randomized Trial of a Standing Physician Order Entry Intervention for Colony Stimulating Factor use among Patients at Intermediate Risk for Febrile Neutropenia (TrACER) (SWOG S1415)

D Hershman;A Bansal;S Sullivan;G Lyman;W Barlow;K Arnold;K Watabayashi;A Bell-Brown;N Le-Lindqwister;C Dul;U Brown-Glaberman;R Behrens;V Vogel;N Alluri;S Ramsey Journal of Clinical Oncology Jan 20;41(3):590-598

PMid: PMID36228177 | PMC number: PMC9870230

Intervention Nonadherence in the TrACER (S1415CD) Study: A Pragmatic Randomized Trial of a Standardized Order Entry for CSF Prescribing

DL Hershman;A Bansal;W Barlow;K Arnold;K Watabayashi;A Bell-Brown;S Sullivan;G Lyman;S Ramsey JCO Oncology Practice Dec;19(12):1160-1167

PMid: PMID37788414 | PMC number: PMC10732502

Impact of Treatment Experience on Patient Knowledge of Colony Stimulating Factors Among Patients Receiving Cancer Chemotherapy: Evidence from S1415CD, A Large Pragmatic Trial

G Lyman;A Bansal;S Sullivan;K Arnold;W Barlow;D Hershman;T Lad;S Ramsey Supportive Care in Cancer Sep 28;31(10):598

PMid: PMID37770704 | PMC number: PMC11060514

2022

Successes and challenges of implementing a cancer care delivery intervention in community oncology practices: lessons learned from SWOG S1415CD

K Watabayashi;A Bell-Brown;K Kreizenbeck;K Egan;G Lyman;D Hershman;K Arnold;A Bansal;W Barlow;S Sullivan;S Ramsey BMC Health Services Research Apr 1;22(1):432

PMid: PMID35365139 | PMC number: PMC8973954

Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting

K Arnold;G Anderson;D Weatherbee Society for Clinical Trials (MAY 15-18, 2022 San Diego, CA), poster

A Pragmatic Cluster-Randomized Trial of a Standing Physician Order Entry Intervention for Colony Stimulating Factor use among Patients at Intermediate Risk for Febrile Neutropenia (SWOG S1415CD)

DL Hershman;A Bansal;S Sullivan;G Lyman;W Barlow;K Arnold;K Watabayashi;A Bell-Brown;N Le-Lindqwister;C Dul;U Brown-Glaberman;R Behrens;V Vogel;N Alluri;SD Ramsey J Clin Oncol 40, 2022 (suppl 16; abstr 1518), poster 112; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

A pragmatic cluster-randomized trial of a computerized clinical decision support system to improve colony stimulating factor prescribing for cancer patients receiving myelosuppressive chemotherapy (SWOG S1415CD)

S Ramsey;A Bansal;S Sullivan;G Lyman;W Barlow;K Arnold;K Watabayashi;A Bell-Brown;N Le-Lindqwister;C Dul;U Brown-Glaberman;R Behrens;V Vogel;N Alluri;D Hershman J Clin Oncol 40, 2022 (suppl 16; abstr 1525), poster 119; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

Effects of a guideline-informed clinical decision support system intervention to improve colony stimulating factor prescribing: A Pragmatic Cluster-Randomized Trial

S Ramsey;S Bansal;S Sullivan;G Lyman;W Barlow;K Arnold;K Watabayashi;A Bell-Brown;K Kreizenbeck;N Le-Lindqwister;C Dul;U Brown-Glaberman;R Behrens;V Vogel;N Alluri;D Hershman JAMA Network Open Oct 3;5(10):e2238191

PMid: PMID36279134 | PMC number: PMC9593234

Can order entry systems improve oncology practice? The TrACER Experience

S Ramsey;A Bansal;W Barlow;K Arnold;A Bell-Brown;K Watabayashi;K Kreizenbeck;G Lyman;S Sullivan;D Hershman ASCO Quality Care Symposium (September 30 - October 1, 2022, Chicago, IL), poster

An Evaluation of Stakeholder Engagement in Comparative Effectiveness Research: Lessons Learned from SWOG S1415CD

A Bell-Brown;K Watabayashi;K Kreizenbeck;S Ramsey;A Bansal;W Barlow;G Lyman;DL Hershman;A Mercurio;B Segarra-Vazquez;F Kurttila;J Myers;J Golenski;J Johnson;R Erwin;S Sullivan Journal of Comparative Effectiveness Research Dec;11(18):1313-1321

PMid: PMID36378570 | PMC number: PMC9832319

Intervention non-adherence in a pragmatic randomized trial of a standardized order entry for colony stimulating factor prescribing

D Hershman;A Bansal;W Barlow;K Arnold;A Bell-Brown;K Watabayashi;K Kreizeneck;S Sullivan;G Lyman;S Ramsey ASCO Quality Care Symposium (September 30 - October 1, 2022, Chicago, IL), oral presentation

2019

Effective Stakeholder Engagement: Design and Implementation of a Clinical Trial (SWOG S1415CD) to Improve Cancer Care

S Barger;A Bell-Brown;TB Bott;AM Ciccarella;J Golenski;M Gorman;J Johnson;K Kreizenbeck;F Kurttila;G Mason;J Myers;C Seigel;JL Wade, III;G Walia;K Watabayashi;GH Lyman;S Sullivan;S Ramsey BMC Medical Research Methodology Jun 11;19(1):119

PMid: PMID31185918 | PMC number: PMC6560751

2018

Implementing an EHR Guideline-based Intervention in Paper Ordering Systems

A Bell-Brown;K Egan;K Kreizenbeck;K Watabayashi;G Lyman;D Hershman;A Bansal;W Barlow;S Sullivan;S Ramsey J Clin Oncol 36 (suppl 30; abstr 56)ASCO Quality Care Symposium (Sept 28-29, 2018, Phoenix, AZ), poster

Impact of clinic characteristics on the adoption of a guideline-based standing order algorithm and patient accrual in the pragmatic cluster-randomized trial SWOG S1415CD (NCT02728596)

K Watabayashi;A Bell-Brown;K Egan;K Kreizenbeck;G Lyman;D Hershman;A Bansal;W Barlow;S Sullivan;S Ramsey J Clin Oncol 36 (suppl 30; abstr 60); ASCO Quality Care Symposium (Sept 28-29, 2018, Phoenix, AZ), poster

The Influence of Patient Engagement on the Design and Implementation of a Clinical Trial to Improve Cancer Care Delivery

S Barger;S Sullivan;G Lyman;D Hershman;A Bell-Brown;K Watabayashi;K Egan;K Kreizenbeck;AM Cicarella;M Gorman;B Bott;G Walia;J Johnson;C Siegel;E Railey;G Mason;B Erwin;F Kurtilla;B Segarra-Vasquez;S Ramsey J Clin Oncol 36 (suppl 30; abstr 223); ASCO Quality Care Symposium (Sept 28-29, 2018, Phoenix, AZ), poster

From A to Xeloda: Practical considerations for implementing a chemotherapy regimen ordering system intervention

K Egan;A Bell-Brown;K Kreizenbeck;K Watabayashi;G Lyman;D Hershman;A Bansal;W Barlow;S Sullivan;S Ramsey J Clin Oncol 36 (suppl 30; abstr 57); ASCO Quality Care Symposium (Sept 28-29, 2018, Phoenix, AZ), poster

2017

Consistency of standing orders for primary prophylactic CSF within a national network of community oncology practices: SWOG Intergroup Trial S1415CD

S Ramsey;DL Hershman;A Bell-Brown;K Watabayashi;K Kreizenbeck;S Sullivan;A Bansal;W Barlow;K Arnold;G Lyman AACR Annual Meeting 2017 (April 1-5, 2017, Washington, DC), poster, abst. 2767/ 7

A Stakeholder-Informed Randomized, Controlled Comparative Effectiveness Study of an Order Prescribing Intervention to Improve Colony Stimulating Factor use for Cancer Patients Receiving Myelosuppressive Chemotherapy: The TrACER Study

A Bansal;SD Sullivan;D Hershman;G Lyman;W Barlow;JS McCune;SD Ramsey Journal of Comparative Effectiveness Research Jul;6(5):461-470. Epub 2017 Jul 7

PMid: PMID28686055 | PMC number: PMC5827800

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