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Completed

NCT Number: NCT02788565

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

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.

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Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skane University Hospital, Lund, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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'.

Secondary outcomes

  1. 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

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

    Time frame: Day 1

  3. 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?"

  4. Mean number of packs of H01CB03 and H01CB02 purchased.

    Time frame: Retrospective data collection of a 1 year period

  5. Median number of packs of H01CB03 and H01CB02 purchased.

    Time frame: Retrospective data collection of a 1 year period

  6. 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

  7. 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

  8. 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

  9. Median time - visits to primary care for injections; visits to treating physician at hospital; time to travel

    Time frame: Day 1

  10. Median time for giving injections of SSA in subjects, derived as the time reported in the nurse questionnaire.

    Time frame: Day 1

  11. Proportion of nurses who reported "moderately" or "very" or "very much" confidence in giving injections

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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)

Acronym: STREET

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2016
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.