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United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting (PREF-NET)

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ClinicalTrials.gov Identifier: NCT04649580
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL)

Condition or disease
Neuroendocrine Tumours (NET)

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Patient-Reported Study To Assess The Patient Preference Of Treatment Administration Setting, Impact On Health-Related Quality Of Life, Work Productivity, Wider Societal Costs And Healthcare Utilisation For Patients With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Prescribed Somatuline® Autogel® In A Homecare Setting and Hospital Setting.
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021


Group/Cohort
Online Survey
One-to-one interviews



Primary Outcome Measures :
  1. Patient preferences of treatment administration setting (homecare or hospital) [ Time Frame: Baseline ]
    Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital


Secondary Outcome Measures :
  1. Demographic characteristics of enrolled patients with GEP-NETs [ Time Frame: Baseline ]
    Age (years); Gender (male, female); Current employment status: full time, part time, unemployed, retired, student, homemaker, unpaid carer)

  2. Clinical characteristics of enrolled patients with GEP-NETs [ Time Frame: Baseline ]
    Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide

  3. Patient-reported impact on healthcare resource use [ Time Frame: Baseline ]
    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.

  4. Patient-reported impact on wider societal costs [ Time Frame: Baseline ]
    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.

  5. Patient-reported work productivity [ Time Frame: Baseline ]
    Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire

  6. Description of patient-reported HRQoL [ Time Frame: Baseline ]
    Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.)

  7. Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting; [ Time Frame: 1 month ]
    Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.

  8. Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health [ Time Frame: 1 month ]
    Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
UK patients with NET receiving Somatuline Autogel injections at home
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of GEP-NETs
  • Patients on prescribed lanreotide Autogel®;
  • Patients who have switched from hospital to homecare administration setting at least 2 months ago
  • Patients judged to be on a stable dose; 120mg for tumour control or >1 injection at same dose for symptom control

Exclusion Criteria:

  • Patients who decline or lack capacity to consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649580


Contacts
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Contact: Ipsen Recruitment Enquiries see email clinical.trials@ipsen.com

Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom, B15 2GW
Cardiff and Vale University LHB Recruiting
Cardiff, United Kingdom, CF14 4HH
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, United Kingdom, CV2 2DX
Royal Free London NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04649580    
Other Study ID Numbers: A-GB-52030-394
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: October 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue