Understanding the Impact of Drug Shortages on Oncology Care Delivery
NCT ID: NCT03953027
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2018-07-01
2025-06-18
Brief Summary
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Detailed Description
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I. To prospectively estimate the proportion of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs.
SECONDARY OBJECTIVES:
I. To prospectively estimate the rate of cancer care delivery problems attributable to a drug shortage of infusional therapeutic oncology drugs for patient populations treated with: a) all cancer drugs, b) all cancer drugs in shortage, and c) each individual cancer drug in shortage.
II. To assess strategies practices used during drug shortages (e.g., manage costs, stockpile, hire staff).
TERTIARY OBJECTIVES:
I. To assess practice factors (e.g., case mix, size, practice type) associated with the likelihood that a practice reports cancer care delivery problems.
II. To describe how practice-level strategies in response to drug shortages vary by practice characteristics.
III. To describe the possible effects on clinical trials (e.g., unable to enroll a patient or changing to an alternative treatment).
IV. To characterize cancer care delivery problems attributable to a shortage of supportive care agents.
V. To characterize cancer care delivery problems attributable to a shortage of oral anti-cancer agents.
OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Drug Shortage Incident Reports in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey every 3 months for one year (4 total).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Health Services Research (surveys about drug shortages)
At baseline, practice sites complete a Baseline Drug Shortage Survey and Pharmacy Baseline Survey; Drug Shortage Incident Reports are completed in real time as cancer care delivery problems occur; and the Quarterly Follow-Up Survey Number Treated Report every 3 months for one year (4 total).
Survey Administration
Ancillary studies
Interventions
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Survey Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* Practice sites must have a valid Cancer Therapy Evaluation Program (CTEP) identification number
* Practice sites may or may not share a pharmacy
* Provide infusional chemotherapy treatment (either inpatient or outpatient)
Exclusion Criteria
* Practice sites that do not provide infusional chemotherapy
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester NCORP Research Base
OTHER
Responsible Party
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Elaine Hill
Assistant Professor
Principal Investigators
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Elaine Hill, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Southeast Clinical Oncology Research Program
Winston-Salem, North Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Countries
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Other Identifiers
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NCI-2018-03601
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC18004CD
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-18004CD
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-18004CD
Identifier Type: OTHER
Identifier Source: secondary_id
URCC18004CD
Identifier Type: -
Identifier Source: org_study_id
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