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Significant and complex challenges had since been identified during recent testing phases. After their assessment, Ipsendecided to discontinue development of this motorized device in order to not burden participants.
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This study aims to investigate the treatment preferences of patients with Neuroendocrine Tumors (NETS) and nurses who are involved in the care of individuals with NETs. NETs are a type of abnormal growth that can develop in various parts of the body, such as the lungs, pancreas, gastrointestinal tract, or other organs.
NETs originate from specialized cells called neuroendocrine cells, which are responsible for producing hormones in our bodies.
The study focuses on hypothetical preferences regarding the use of two different type of devices for administering Somatostatin analogues (SSAs), which could be used in the treatment of NETs.
SSAs work by imitating the actions of a hormone called somatostatin that naturally exists in our bodies. These treatment help to control the symptoms of NETs by blocking the release of hormones from the tumor cells.
The devices under consideration are a motorized injector versus a manual injector.
Participants in the study will be asked to take part in:
By analysing the choices made by participants, researchers can understand which attributes of the injector devices are most important to patients and nurses.
Individual participation is limited to the interview based on a draft survey (60 minutes) or the final online survey (30 minutes).
No further participation is required beyond this.
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| Measure | Description | Time Frame |
|---|---|---|
| Attribute importance | Using the data from the survey scenarios (the DCE component of the survey) the DCE model estimates the parameters (β's) for each feature (attribute) level. These β's describe the magnitude and direction of influence of each of the attribute (levels) in the choice context. The β's can include negative and positive values which indicate the direction of the effect in relation to the attribute levels. | At the end of the survey completion (approximatively 3 months) |
| Relative attribute importance | Attribute importance is described by the magnitude of the β's (i.e., the size of the values). The magnitude of the β's are interpreted and understood relative to each other (relative attribute importance). | At the end of the survey completion (approximatively 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of segmentation | Identify which patients (e.g., age, gender, tumor grade, carcinoid syndrome status, treatment history) and nurses characteristics (e.g., years of experience, caseload, public or private place of work, NETs specialist clinic or not) are predictive of the assessment of the benefits and risks of treatment options (segmentation) Segmentation: The econometric methods to be employed will recognise that preferences may vary across participants, even after controlling for observed characteristics like treatment experiences. This allows for preference heterogeneity (i.e., different participants can have different marginal utility or parameter weights for each of the features). |
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Inclusion Criteria:
Patients (cognitive interviews)
Patients (online survey and DCE)
Nurses (cognitive interviews)
Nurses (online survey and DCE)
Exclusion Criteria:
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The study population includes:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPPRE | Sydney | 2000 | Australia |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| At the end of the survey completion (approximatively 3 months) |
| Predicted uptake (preference share) | Preference share: Predicted uptake for the different treatments available will be calculated, based on attribute importance.. | At the end of the survey completion (approximatively 3 months) |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
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