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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05922579
Registration number
NCT05922579
Ethics application status
Date submitted
19/06/2023
Date registered
28/06/2023
Titles & IDs
Public title
A Study to Collect the Somatuline® Injector Device Preferences of Patients Living With Neuroendocrine Tumor (NET) and Nurses Involved in the Care of Patients With NET
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Scientific title
Treatment Preferences for Somatuline® Injector Devices: A Discrete Choice Experiment (DCE) of Patients With Neuroendocrine Tumors (NETs) and Nurses in the United States (US) and Canada
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Secondary ID [1]
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CLIN-52030-458
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumors
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Attribute importance
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Assessment method [1]
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Using the data from the survey scenarios (the DCE component of the survey) the DCE model estimates the parameters (ß's) for each feature (attribute) level. These ß's describe the magnitude and direction of influence of each of the attribute (levels) in the choice context. The ß's can include negative and positive values which indicate the direction of the effect in relation to the attribute levels.
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Timepoint [1]
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At the end of the survey completion (approximatively 3 months)
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Primary outcome [2]
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Relative attribute importance
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Assessment method [2]
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Attribute importance is described by the magnitude of the ß's (i.e., the size of the values). The magnitude of the ß's are interpreted and understood relative to each other (relative attribute importance).
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Timepoint [2]
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At the end of the survey completion (approximatively 3 months)
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Secondary outcome [1]
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Measures of segmentation
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Assessment method [1]
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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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Timepoint [1]
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At the end of the survey completion (approximatively 3 months)
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Secondary outcome [2]
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Predicted uptake (preference share)
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Assessment method [2]
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Preference share: Predicted uptake for the different treatments available will be calculated, based on attribute importance..
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Timepoint [2]
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At the end of the survey completion (approximatively 3 months)
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Eligibility
Key inclusion criteria
Patients (cognitive interviews)
* Aged 18 years or over
* Reside in the US or Canada
* Have been diagnosed with NETs by a healthcare professional (based on self-report and confirmed via data quality checks)
* Have any SSA treatment experience in the past 2 years
* Be fluent in spoken and written English
* Have read, understood, and consented to participate in the study
* Be able to complete the survey on a standard-sized tablet device (minimum 10 inches), laptop, or desktop computer
* Be able and willing to screenshare with the interviewer
Patients (online survey and DCE)
* Aged 18 years or over
* Reside in the US or Canada
* Have been diagnosed with NETs by a healthcare professional (based on self-report and confirmed via data quality checks)
* Have any SSA treatment experience in the past 2 years
* Be fluent in spoken and written English
* Have read, understood, and consented to participate in the study
* Be able to complete the survey on a standard-sized tablet device (minimum 10 inches), laptop, or desktop computer
* Have not participated in the cognitive interviews
Nurses (cognitive interviews)
* Reside in the US or Canada
* Nurse with at least 12 months experience caring for patients with NETs
* Have administered at least one long-acting SSA injection to a patient with NETs in the past 12 months
* Be fluent in spoken and written English
* Have read, understood, and consented to participate in the study
* Be able to complete the survey on a standard-sized tablet device (minimum 10 inches), laptop, or desktop computer
* Be able and willing to screenshare with the interviewer
Nurses (online survey and DCE)
* Reside in the US or Canada
* Nurse with at least 12 months experience caring for patients with NETs
* Have administered at least one long-acting SSA injection to a patient with NETs in the past 12 months
* Be fluent in spoken and written English or Canadian French
* Have read, understood, and consented to participate in the study
* Be able to complete the survey on a standard-sized tablet device (minimum 10 inches), laptop, or desktop computer
* Have not participated in the cognitive interviews
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* No access to internet
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2023
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Sample size
Target
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Accrual to date
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Final
191
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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CAPPRE - Sidney
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Recruitment postcode(s) [1]
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2000 - Sidney
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ipsen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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: 1. An interview based on a draft survey: 60-minute interview over videocall, to examine participants understanding of the online survey; or 2. Final online survey: 30-minute online survey. This involves presenting patients and nurses with different treatment options and asking them to choose their preferred option. 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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Trial website
https://clinicaltrials.gov/study/NCT05922579
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ipsen Medical Director
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Address
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Ipsen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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.
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Available to whom?
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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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05922579