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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
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
Secondary ID [1] 0 0
CLIN-52030-458
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Attribute importance
Timepoint [1] 0 0
At the end of the survey completion (approximatively 3 months)
Primary outcome [2] 0 0
Relative attribute importance
Timepoint [2] 0 0
At the end of the survey completion (approximatively 3 months)
Secondary outcome [1] 0 0
Measures of segmentation
Timepoint [1] 0 0
At the end of the survey completion (approximatively 3 months)
Secondary outcome [2] 0 0
Predicted uptake (preference share)
Timepoint [2] 0 0
At the end of the survey completion (approximatively 3 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* No access to internet

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2023
Sample size
Target
Accrual to date
Final
191
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CAPPRE - Sidney
Recruitment postcode(s) [1] 0 0
2000 - Sidney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
Available to whom?
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/members/ourmembers/


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