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NCT05922579·Not applicable·OBSERVATIONAL

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

Status

Terminated

Phase

Not applicable

Enrollment

191

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Jun 28, 2023

  2. Study start

    Jun 15, 2023

  3. Primary completion

    Dec 1, 2023

  4. Study completion

    Dec 1, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Feb 29, 2024

Outcomes

What the study measures.

Primary outcomes

Attribute importance

Time frame · At the end of the survey completion (approximatively 3 months)

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.

Relative attribute importance

Time frame · At the end of the survey completion (approximatively 3 months)

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).

Secondary outcomes

Measures of segmentation

Time frame · 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) 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).

Predicted uptake (preference share)

Time frame · At the end of the survey completion (approximatively 3 months)

Preference share: Predicted uptake for the different treatments available will be calculated, based on attribute importance..

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

Australia. Showing up to 24 locations stored in the fast local snapshot.

CAPPRE

Sydney, Australia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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