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

Neuroendocrine Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05922579
• Other study ID #: CLIN-52030-458
• Status: Terminated
• Start date: June 15, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• No access to internet

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Locations

Country	Name	City	State
Australia	CAPPRE	Sidney

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attribute importance	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.	At the end of the survey completion (approximatively 3 months)
Primary	Relative attribute importance	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).	At the end of the survey completion (approximatively 3 months)
Secondary	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).	At the end of the survey completion (approximatively 3 months)
Secondary	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)