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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Survey | |||
| One-to-one interviews |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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UK patients with NET receiving Somatuline Autogel injections at home
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2GW | United Kingdom | |||
| Cardiff and Vale University LHB |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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 |
| Cardiff |
| CF14 4HH |
| United Kingdom |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Liverpool University Hospitals NHS Foundation Trust | Liverpool | L7 8XP | United Kingdom |
| Royal Free London NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| D009380 | Neoplasms, Nerve Tissue |