Understanding the Impact of Drug Shortages on Oncology Care Delivery

University of Rochester NCORP Research Base

Status: Withdrawn

Conditions: Staff; Community Practice

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03953027

UG1CA189961 (U.S. NIH Grant/Contract)

NCI-2018-03601 (Registry Identifier)

URCC18004CD (Other Identifier)

URCC-18004CD (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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).

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• Practices sites without valid CTEP identification (ID)
• Practice sites that do not provide infusional chemotherapy

Trial design

0 participants in 1 patient group

Health Services Research (surveys about drug shortages)

Description:

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).

Treatment:

Other: Survey Administration