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

June 1, 2020 updated by: Ipsen

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)

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22241
        • Skane University Hospital
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Treatment clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-SE-52030-353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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