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

Sponsor
Ipsen (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05922579
Collaborator
(none)
191
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    191 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Jun 22, 2023
    Anticipated Primary Completion Date :
    Aug 31, 2023
    Anticipated Study Completion Date :
    Aug 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Attribute importance [At the end of the survey completion (approximatively 3 months)]

      Identify the treatment attributes and injector device features valued by patients and nurses (attribute importance)

    2. Relative attribute importance [At the end of the survey completion (approximatively 3 months)]

      Estimate the relative importance of different treatment attributes and injector device features (relative attribute importance)

    Secondary Outcome Measures

    1. Measures of segmentation [At the end of the survey completion (approximatively 3 months)]

      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)

    2. Predicted uptake (preference share) [At the end of the survey completion (approximatively 3 months)]

      Estimate the predicted uptake (preference share) for different injector devices

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT05922579
    Other Study ID Numbers:
    • CLIN-52030-458
    First Posted:
    Jun 28, 2023
    Last Update Posted:
    Jun 28, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2023