Clinical trial NCT04649580: United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumours (NET)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK patients with NET receiving Somatuline Autogel injections at home

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)


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

Primary outcomes:
measure: Patient preferences of treatment administration setting (homecare or hospital)
timeFrame: Baseline
Secondary outcomes:
measure: Demographic characteristics of enrolled patients with GEP-NETs
timeFrame: Baseline
measure: Clinical characteristics of enrolled patients with GEP-NETs
timeFrame: Baseline
measure: Patient-reported impact on healthcare resource use
timeFrame: Baseline
measure: Patient-reported impact on wider societal costs
timeFrame: Baseline
measure: Patient-reported work productivity
timeFrame: Baseline
measure: Description of patient-reported HRQoL
timeFrame: Baseline
measure: Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting;
timeFrame: 1 month
measure: Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health
timeFrame: 1 month
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University LHB
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: