跳至主要内容
临床试验/NCT05922579
NCT05922579终止不适用

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

Ipsen1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2023年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Ipsen
入组人数
191
试验地点
1
主要终点
Attribute importance

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No access to internet

结局指标

主要结局

Attribute importance

时间窗: 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

时间窗: 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).

次要结局

  • Predicted uptake (preference share)(At the end of the survey completion (approximatively 3 months))
  • Measures of segmentation(At the end of the survey completion (approximatively 3 months))

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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