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Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours (STREET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788565
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date May 27, 2016
First Posted Date June 2, 2016
Last Update Posted Date June 2, 2020
Study Start Date March 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2016)
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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 16, 2016)
  • 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 Measures
 (submitted: May 27, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life, Treatment Experience and Cost of Treatment With Somatostatin Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours
Official Title SOMATOSTATIN TREATMENT EXPERIENCE TRIAL An Observational Cross Sectional Trial Investigating Quality of Life, Treatment Experience and Direct Cost of Treatment With Somatostatin Analogues in Subjects With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Treatment clinic
Condition Gastroenteropancreatic Neuroendocrine Tumours
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2017)
156
Original Estimated Enrollment
 (submitted: May 27, 2016)
200
Actual Study Completion Date December 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Signed informed consent
  • Diagnosed with a Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET) and treated with SSA for at least three months but not more than 3 years
  • GEP-NET proliferation index Ki 67 <10%
  • Over 18 years of age

Exclusion Criteria:

  • No specific exclusion criteria defined
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02788565
Other Study ID Numbers A-SE-52030-353
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date June 2020