NCT04649580

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

September 23, 2020

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient preferences of treatment administration setting (homecare or hospital)

    Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital

    Baseline

Secondary Outcomes (8)

  • Demographic characteristics of enrolled patients with GEP-NETs

    Baseline

  • Clinical characteristics of enrolled patients with GEP-NETs

    Baseline

  • Patient-reported impact on healthcare resource use

    Baseline

  • Patient-reported impact on wider societal costs

    Baseline

  • Patient-reported work productivity

    Baseline

  • +3 more secondary outcomes

Study Arms (2)

Online Survey

One-to-one interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UK patients with NET receiving Somatuline Autogel injections at home

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

Location

Cardiff and Vale University LHB

Cardiff, CF14 4HH, United Kingdom

Location

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2020

First Posted

December 2, 2020

Study Start

April 27, 2021

Primary Completion

June 5, 2022

Study Completion

June 5, 2022

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations