Neuroendocrine Tumours (NET)
Conditions
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)
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
| 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. |
| 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. |
| Patient-reported work productivity | Baseline | Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire |
Countries
United Kingdom
Outcome results
None listed