Clinical trial NCT03953027: Understanding the Impact of Drug Shortages on Oncology Care Delivery
Official title: Understanding the Impact of Drug Shortages on Oncology Care Delivery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Community Practice
Staff
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-16
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs
timeFrame: Baseline up to 12 months
measure: Change to less effective treatment
timeFrame: Up to 12 months
measure: Change to more toxic treatment
timeFrame: Up to 12 months
measure: Delay in treatment
timeFrame: Up to 12 months
measure: Medication error/near miss
timeFrame: Up to 12 months
Secondary outcomes:
measure: Rate of cancer care delivery problems (CCDPs)
timeFrame: Up to 12 months
measure: Strategies practices use
timeFrame: Baseline up to 12 months
Other outcomes:
measure: Practice factors
timeFrame: Baseline up to 12 months
measure: Variation in practice characteristics
timeFrame: Baseline up to
measure: Effects of drug shortages on clinical trials
timeFrame: Up to 12 months
measure: Cancer care delivery problems associated with supportive care agents
timeFrame: Up to 12 months
measure: Cancer care delivery problems associated with oral anticancer agents
timeFrame: Up to 12 months
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Medical Health Center
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Program
state: North Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Elaine Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References: