Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05922579




Registration number
NCT05922579
Ethics application status
Date submitted
19/06/2023
Date registered
28/06/2023
Date last updated
29/02/2024

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
Terminated
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05922579
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05922579