Clinical Trial: Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Lanreotide and Octreotide LAR for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs): An Observational Time and Motion Analysis

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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: The total time for product preparation and administration [ Time Frame: Day 1 ]

Total drug delivery time


Original Primary Outcome: The total time for product preparation and administration (i.e. total drug delivery time). [ Time Frame: Day 1 ]

Current Secondary Outcome:

  • Total patient wait time for administration [ Time Frame: 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 [ Time Frame: Day 1 ]
    The number of clogging episodes for lanreotide and octreotide LAR will be recorded and compared.
  • Healthcare resource utilization [ Time Frame: 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 [ Time Frame: Day 1 and at the end of the study (approximately 3 months) ]
    Assessed by pharmacist and/or nurse completing questionnaire
  • Patient satisfaction [ Time Frame: Day 1 ]
    Assessed by patient completing questionnaire


Original Secondary Outcome:

  • Total patient wait time for administration [ Time Frame: 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 [ Time Frame: Day 1 ]
  • Healthcare resource utilization [ Time Frame: 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 [ Time Frame: Day 1 and at the end of the study (approximately 3 months) ]
    Assessed by pharmacist and/or nurse completing questionnaire
  • Patient satisfaction [ Time Frame: Day 1 ]
    Assessed by patient completing questionnaire


Information By: Ipsen

Dates:
Date Received: December 30, 2016
Date Started: April 2017
Date Completion: October 2017
Last Updated: April 7, 2017
Last Verified: April 2017