Gastroenteropancreatic Neuroendocrine Tumours
Conditions
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.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with injection problems according to the subject | Day 1 | Subject questionnaire asks In your opinion, how did the last injection go?, subject chooses either 'no problems' or 'problems occurred'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual. | Day 1 | — |
| Subject experience: proportion of subjects reporting much or very much anxiety in subject questionnaire. | Day 1 | Subjects asked To what extent do you feel anxiety before the injection? |
| Mean number of packs of H01CB03 and H01CB02 purchased. | Retrospective data collection of a 1 year period | — |
| Median number of packs of H01CB03 and H01CB02 purchased. | 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. | Retrospective data collection of a 1 year period | — |
| Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual. | Day 1 | Mean physical health score and mean mental health score in SF-12 derived according to the SF-12 manual |
| Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire. | Day 1 | — |
| Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel | Day 1 | — |
| Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire. | Day 1 | — |
| Proportion of nurses who reported moderately or very or very much confidence in giving injections | Day 1 | — |
| Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction. | Retrospective data collection of a 1 year period | — |
Countries
Sweden
Outcome results
None listed