NCT03017690CompletedNot Applicable
Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 22
- Locations
- 5
- Primary Endpoint
- The total time for product preparation and administration
Study Overview
Brief Summary
An observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide LAR.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women must be 18 years of age or older
- •A current diagnosis of advanced, unresectable GEP-NET
- •Provided written informed consent to participate in the study
- •Currently receiving lanreotide or octreotide LAR and has received at least one prior injection of current somatostatin analogues (SSA).
Exclusion Criteria
- •Receiving treatment with lanreotide or octreotide LAR as part of a clinical trial
- •Scheduled to receive a dose of lanreotide or octreotide LAR that would necessitate more than 1 injection on the same day
- •Scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment
- •Known hypersensitivity to somatostatin analogues
Outcomes
Primary Outcomes
The total time for product preparation and administration
Time Frame: Day 1
Total drug delivery time
Secondary Outcomes
- Number of clogging episodes(Day 1)
- Patient satisfaction(Day 1)
- Healthcare resource utilization(Day 1)
- Total patient wait time for administration(Day 1)
- Pharmacist and/or nurse satisfaction and product preference(Day 1 and at the end of the study (approximately 3 months))
Investigators
Study Sites (5)
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