Gastroenteropancreatic Neuroendocrine Tumor
Conditions
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total time for product preparation and administration | Day 1 | Total drug delivery time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total patient wait time for administration | Day 1 | For the purposes of this study, total patient wait time refers to the time the patient checks in at the infusion room until completion of drug administration and discharge of the patient from the infusion room. |
| Number of clogging episodes | Day 1 | The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared. |
| Healthcare resource utilization | Day 1 | The materials used for the preparation of lanreotide and octreotide LAR will be recorded and compared. |
| Pharmacist and/or nurse satisfaction and product preference | Day 1 and at the end of the study (approximately 3 months) | Assessed by pharmacist and/or nurse completing questionnaire |
| Patient satisfaction | Day 1 | Assessed by patient completing questionnaire |
Countries
United States
Outcome results
None listed