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

Completed

• Conditions: Gastroenteropancreatic Neuroendocrine Tumours

• Registration Number: NCT02788565
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-06-02
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.	Day 1
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
Mean 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
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
Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel	Day 1
Quality of life, mean mental health score in SF-12 derived according to the SF-12 manual.	Day 1
Median number of packs of H01CB03 and H01CB02 purchased.	Retrospective data collection of a 1 year period
Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections	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?"

Trial Locations

Locations (2)

Skane University Hospital; 🇸🇪 Lund, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden