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

NCT05922579 | Terminated

• 1 other identifier: CLIN-52030-458
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

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. 1.An interview based on a draft survey: 60-minute interview over videocall, to examine participants understanding of the online survey; or
2. 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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• Measures of segmentation

  At the end of the survey completion (approximatively 3 months)

• Predicted uptake (preference share)

  At the end of the survey completion (approximatively 3 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes: 1. patients with NETs in the US or Canada having had any SSA treatment experience in the past 2 years 2. nurses who treat NETs in the US or Canada, having administered at least one long-acting SSA injection to a patient with NETs in the past 12 months

You may qualify if:

• 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

You may not qualify if:

• No access to internet

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

CAPPRE

Sydney, 2000, Australia

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: June 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).

Locations

AU (1)