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

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ClinicalTrials.gov Identifier: NCT02788565
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease
Gastroenteropancreatic Neuroendocrine Tumours

Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Analogues in Patients With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETS)
Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016





Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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

  2. Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual. [ Time Frame: Day 1 ]
  3. 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?"

  4. Mean number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  5. Median number of packs of H01CB03 and H01CB02 purchased. [ Time Frame: Retrospective data collection of a 1 year period ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel [ Time Frame: Day 1 ]
  10. Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire. [ Time Frame: Day 1 ]
  11. Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Treatment clinic
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788565


Locations
Sweden
Skane University Hospital
Lund, Sweden, 22241
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Peter Myrenfors, M.D. Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02788565     History of Changes
Other Study ID Numbers: A-SE-52030-353
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Neuroendocrine Tumors
Intestinal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs