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 |
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Recruitment Status :
Completed
First Posted : June 2, 2016
Last Update Posted : June 2, 2020
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
- Study Details
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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: | 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) |
| Study Start Date : | March 2016 |
| Actual Primary Completion Date : | October 2016 |
| Actual Study Completion Date : | December 2016 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- 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 :
- 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 ]
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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: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT02788565 |
| Other Study ID Numbers: |
A-SE-52030-353 |
| First Posted: | June 2, 2016 Key Record Dates |
| Last Update Posted: | June 2, 2020 |
| Last Verified: | June 2020 |
Additional relevant MeSH terms:
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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 |