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.

Ipsen5 sites in 1 country80 target enrollmentApril 27, 2021

ConditionsNeuroendocrine Tumours (NET)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuroendocrine Tumours (NET)
Sponsor: Ipsen
Enrollment: 80
Locations: 5
Primary Endpoint: Patient preferences of treatment administration setting (homecare or hospital)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

June 5, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health(1 month)
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)
Description of patient-reported HRQoL(Baseline)
Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting;(1 month)