Clinical Trial: Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: STREET- SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional International Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin

Brief Summary: Data from this study will contribute additional knowledge regarding patient outcomes and direct somatostatin analogue (SSA) treatment related costs in clinical practice in the Nordic countries. Such knowledge can be of importance in a treatment decision, decision support for development of care, follow up and training of both patients and primary care nurses.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Proportion of subjects with injection problems according to the subject [ Time Frame: Day 1 ]

Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual. [ Time Frame: Day 1 ]
    Mean physical health score and mean mental health score in SF-12 derived according to the SF-12 manual
  • Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual. [ Time Frame: Day 1 ]
  • Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire. [ Time Frame: Day 1 ]
    Subjects asked "To what extent do you feel anxiety before the injection?"
  • Mean number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire. [ Time Frame: Day 1 ]
  • Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel [ Time Frame: Day 1 ]
  • Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire. [ Time Frame: Day 1 ]
  • Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections [ Time Frame: Day 1 ]


Original Secondary Outcome:

  • Quality of life [ Time Frame: Day 1 ]
    Mean physical health score and mean mental health score in SF-12 derived according to the SF-12 manual
  • Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire. [ Time Frame: Day 1 ]
    Subjects asked "To what extent do you feel anxiety before the injection?"
  • Mean number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. [ Time Frame: Retrospective data collection of a 1 year period ]
  • Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire. [ Time Frame: Day 1 ]
  • Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel [ Time Frame: Day 1 ]
  • Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire. [ Time Frame: Day 1 ]
  • Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections [ Time Frame: Day 1 ]


Information By: Ipsen

Dates:
Date Received: May 27, 2016
Date Started: March 2016
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017