Understanding the Impact of Drug Shortages on Oncology Care Delivery
Hematopoietic Malignancies
Solid Tumor
0 Years and older, Male and Female
URCC18004CD (primary)
URCC-18004CD
URCC-18004CD
NCI-2018-03601
Summary
This trial studies the impact of drug shortages on oncology care delivery. Gathering information about cancer drug shortages over time may help researchers improve access to drugs during times of shortages.
Objectives
PRIMARY OBJECTIVE:
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.
VI. To characterize cancer care delivery problems attributable to a drug shortage over time within the same practices.
OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Pharmacy Baseline Survey, and the Baseline Number Treated Report in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey and Quarterly Number Treated Reports every 3 months for one year (4 total).
Eligibility
- Be a primary affiliate or sub-affiliate of an NCORP community site or minority underserved (M/U) community site that is affiliated with the University of Rochester Cancer Center (URCC) NCORP Research Base
* 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)
- RE-ENROLLMENT: Practices that completed data collection prior to December 30, 2022 may submit 1 additional quarter of follow-up
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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