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A pragmatic trial to improve colony-stimulating factors use in cancer
Investigator (PI): Ramsey, Scott
Performing Organization (PO): (Current): Fred Hutchinson Cancer Research Center, Public Health Sciences Division / (206) 667-4266
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2022
Record Source/Award ID: PCORI/PCS-1402-09988
Funding: Total Award Amount: $7,817,799
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: In patients receiving chemotherapy that carries a high risk (more than 20 percent) of febrile neutropenia (FN), a serious infection resulting from loss of white blood cells, clinical practice guidelines recommend use of primary prophylactic colony-stimulating factors (PP-CSF) during the first cycle of chemotherapy to maintain white blood cell count. Guidelines suggest only consideration of PP-CSF in conjunction with chemotherapy carrying an intermediate FN risk (10-20 percent), and it is not recommended for patients receiving low-risk chemotherapy (less than 10 percent risk of FN). Studies show that PP-CSF is both underused and overused, resulting in serious adverse outcomes (FN, interruption of chemotherapy, or reduced dose intensity of chemotherapy) and wasted resources. We propose a pragmatic trial evaluating a guidelines-based, standing order entry system for PP-CSF use versus usual care among breast, colorectal, and lung cancer patients receiving chemotherapy, along with a prospective randomized study of PP-CSF versus no PP-CSF for patients receiving intermediate-risk chemotherapy. The primary outcomes are rates of FN, FN-related emergency room (ER) visits and hospitalizations, health-related quality of life (HRQOL), mortality, and adherence to guidelines. A third aim is to examine CSF use and outcomes among clinics that have already implemented standing CSF order systems. We address two key questions. First, does a guidelines-based, standing PP-CSF order entry system improve prescribing of CSF in accordance with clinical practice guidelines and reduce the risk of FN, compared with usual care in patients receiving chemotherapy? Second, what are the risks and benefits of PP-CSF among patients receiving intermediate-risk chemotherapy? We will enroll men and women aged 21 and over with breast, non-small-cell lung, and colorectal cancer who are receiving chemotherapy. Clinics are first randomized to either standing CSF order entry intervention or usual care. Within the intervention arm, clinics will be randomized again to either PP-CSF or no PP-CSF for all intermediate-risk patients. Patient outcomes to be assessed are PP-CSF prescribing, chemotherapy regimens, adverse events, blood counts, PP-CSF use that is consistent with guidelines, FN events and related ER visits and hospitalizations, and mortality. Patient surveys will assess HRQOL, out-of-pocket costs, and knowledge of the risks, benefits, and costs of CSF. The research questions, study design, recruitment procedures, and study outcomes were designed in consultation with patients, patient advocates, an ethicist, oncologists, insurance plan leaders, policy makers, and leaders of the community clinics where the study will be implemented. Stakeholders will continue to participate in study development, monitoring of progress, and dissemination of results. The study will improve the evidence on the benefits and risks of PP-CSF for commonly prescribed intermediate-risk chemotherapy regimens.
MeSH Terms:
  • Antineoplastic Agents /therapeutic use
  • Breast Neoplasms /*drug therapy
  • /psychology
  • Clinical Pharmacy Information Systems
  • Clinical Trials as Topic
  • Colony-Stimulating Factors /*therapeutic use
  • Colorectal Neoplasms /*drug therapy
  • /psychology
  • Emergency Service, Hospital
  • Guideline Adherence
  • Guidelines as Topic
  • Hospitalization
  • Humans
  • Lung Neoplasms /*drug therapy
  • /psychology
  • Outcome Assessment, Health Care
  • Program Development
  • Program Evaluation
  • Prospective Studies
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Research Design
Country: United States
State: Washington
Zip Code: 98109
UI: 20153598
CTgovId: NCT02728596
Project Status: Ongoing
Record History: ('2019: Project extended to 2022\n2017: Project extended to 2021',)