Clinical trial NCT05922579: 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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Attribute importance
timeFrame: At the end of the survey completion (approximatively 3 months)
measure: Relative attribute importance
timeFrame: At the end of the survey completion (approximatively 3 months)
Secondary outcomes:
measure: Measures of segmentation
timeFrame: At the end of the survey completion (approximatively 3 months)
measure: Predicted uptake (preference share)
timeFrame: At the end of the survey completion (approximatively 3 months)
Other outcomes:
Locations:
city: Sidney
country: Australia
facility: CAPPRE
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: