United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting
- Conditions
- Neuroendocrine Tumours (NET)
- Registration Number
- NCT04649580
- Lead Sponsor
- Ipsen
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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
- Patients who decline or lack capacity to consent to participate in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient preferences of treatment administration setting (homecare or hospital) Baseline Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital
- Secondary Outcome Measures
Name Time Method Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health 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.
Demographic characteristics of enrolled patients with GEP-NETs 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 Baseline Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide
Patient-reported impact on healthcare resource use 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 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 Baseline Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire
Description of patient-reported HRQoL 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; 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.
Trial Locations
- Locations (5)
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Cardiff and Vale University LHB
🇬🇧Cardiff, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
🇬🇧Liverpool, United Kingdom