Current partner codePEPTIDESDE
NCT04649580·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

80

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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)

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Dec 2, 2020

  2. Study start

    Apr 27, 2021

  3. Primary completion

    Jun 5, 2022

  4. Study completion

    Jun 5, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Dec 17, 2024

Outcomes

What the study measures.

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

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)

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

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.

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.

Patient-reported work productivity

Time frame · Baseline

Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire

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.)

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

5 registered sites.

United Kingdom. Showing up to 24 locations stored in the fast local snapshot.

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Cardiff and Vale University LHB

Cardiff, United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.