Clinical trial NCT02788565: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment clinic

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.


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

Primary outcomes:
measure: Proportion of subjects with injection problems according to the subject
timeFrame: Day 1
Secondary outcomes:
measure: Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.
timeFrame: Day 1
measure: Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.
timeFrame: Day 1
measure: Subject experience: proportion of subjects reporting "much" or "very much" anxiety in subject questionnaire.
timeFrame: Day 1
measure: Mean number of packs of H01CB03 and H01CB02 purchased.
timeFrame: Retrospective data collection of a 1 year period
measure: Median number of packs of H01CB03 and H01CB02 purchased.
timeFrame: Retrospective data collection of a 1 year period
measure: Mean number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
timeFrame: Retrospective data collection of a 1 year period
measure: Median number of two consecutive dispensed prescriptions of H01CB03, H01CB02 within seven days during the pre-specified one-year period of retrospective data extraction.
timeFrame: Retrospective data collection of a 1 year period
measure: Median frequency of visits to treating physician in hospital will be derived as number of (frequency) of revisits recorded in the subject questionnaire.
timeFrame: Day 1
measure: Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel
timeFrame: Day 1
measure: Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.
timeFrame: Day 1
measure: Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections
timeFrame: Day 1
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: