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

Ipsen156 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

156

Conditions

Gastroenteropancreatic Neuroendocrine Tumours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Skane University Hospital

Lund, Sweden

Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

Proportion of subjects with injection problems according to the subject

Subject questionnaire asks "In your opinion, how did the last injection go?", subject chooses either 'no problems' or 'problems occurred'.

Time frame: Day 1

Secondary Outcomes

Quality of life, mean physical health score in SF-12 derived according to the SF-12 manual.

Mean physical health score and mean mental health score in SF-12 derived according to the SF-12 manual

Time frame: Day 1

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.

Subjects asked "To what extent do you feel anxiety before the injection?"

Time frame: Day 1

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.

Data from ClinicalTrials.gov

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