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

Study 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)

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.

Conditions
-----------------
Neuroendocrine Tumours (NET)

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Online Survey<br> | |
| One-to-one interviews<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of enrolled patients with GEP-NETs | Age (years); Gender (male, female); Current employment status: full time, part time, unemployed, retired, student, homemaker, unpaid carer) | Baseline | 
| Clinical characteristics of enrolled patients with GEP-NETs | Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide | Baseline | 
| Patient-reported impact on healthcare resource use | 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. | Baseline | 
| Patient-reported impact on wider societal costs | 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. | Baseline | 
| Patient-reported work productivity | Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire | Baseline | 
| Description of patient-reported HRQoL | 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.) | Baseline | 
| Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting; | 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. | 1 month | 
| Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health | 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. | 1 month |