Understanding the Impact of Drug Shortages on Oncology Care Delivery

NCT03953027 | Withdrawn DMC

• 4 other identifiers: URCC18004CDNCI-2018-03601URCC-18004CDUG1CA189961
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Community Practice; Staff

Outcome Measures

Primary Outcomes (5)

• Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs

  Each incident is defined by the drug in shortage and by each cancer care delivery decision (e.g., whenever a recommended treatment plan is developed). All incidents are collected de-identified and aggregated to the practice site. For each drug in shortage during the year (4 quarters) of observation, will determine the number of practices reporting a care delivery problem due to each drug during any quarter and total number of practices treating patients with the drug during any quarter. Will calculate the proportion of affected practices among practices treating patients with the drug as the ratio of these two numbers. Will calculate mean, median, range and evaluate the shape of the distribution of drug specific estimates.

  Baseline up to 12 months

• Change to less effective treatment

  Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The determination of "less effective" will be made by the primary oncology team. "Less effective" treatments can include those that are not the best options per guidelines through the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and other organizations that establish guidelines for oncology care. Given that the primary oncology team is in charge of the patient's care, they will determine if they think the "change" is "less effective" based on their understanding of the patient's diagnosis and clinical situation.

  Up to 12 months

• Change to more toxic treatment

  Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a "change" for this study. The practice site staff will verify with the primary oncology team that they perceive this cancer care delivery issue (e.g., change to another drug) to be more toxic than what was intended. Whether the "change" led to a more toxic treatment or regimen will be determined by the primary oncology team. Teams can utilize their pharmacy staff to help determine if the new treatment or regimen has data to support that it would lead to higher toxicity.

  Up to 12 months

• Delay in treatment

  Assessed with the Drug Shortage Incident Report. Each incident is defined by the drug in shortage and by each cancer care delivery decision (e.g., whenever a recommended treatment plan is developed). Any time there is a change to a treatment regimen due to a drug shortage, the primary oncology team should determine whether or not they perceive this change to be a problem for a patient. When there is a drug shortage that results in a potential issue (e.g., missed dose), the practice site staff will verify with the primary oncology team that they actually perceived this cancer care delivery issue as a problem. The same patient may experience multiple cancer care delivery problems over the course of their treatment. Each of these problems should be reported, de-identified, as separate incidents as they occur.

  Up to 12 months

• Medication error/near miss

  Assessed with the Drug Shortage Incident Report. When there is a shortage of oncology drugs and there is a change in dose, administration, or drug, there can be medication errors in dose or concentration (e.g., drug was supposed to be diluted, but is not). A near miss is when the primary oncology team identifies a potential medication error but the drug was not administered to the patient. Oncology teams should rely on pharmacy staff to help identify and define medication errors and near misses.

  Up to 12 months

Secondary Outcomes (2)

• Rate of cancer care delivery problems (CCDPs)

  Up to 12 months

• Strategies practices use

  Baseline up to 12 months

Other Outcomes (5)

• Practice factors

  Baseline up to 12 months

• Variation in practice characteristics

  Baseline up to

• Effects of drug shortages on clinical trials

  Up to 12 months

Study Arms (1)

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).

Other: Survey Administration

Interventions

Survey Administration OTHER

Ancillary studies

Health Services Research (surveys about drug shortages)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester NCORP Research Base: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Health Partners Inc

Minneapolis, Minnesota, 55454, United States

Location

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina, 27104, United States

Location

Spartanburg Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Study Officials

• Elaine Hill, PhD

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: July 1, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 18, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-04

Locations

US (6)