Neuroendocrine TumorsNCT05922579
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
An observational study of Neuroendocrine Tumors, run by Ipsen at 1 site in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 191 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Jun 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 34Show fewer
- 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
Who cannot join
- No access to internet
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- An interview based on a draft survey: 60-minute interview over videocall, to examine participants understanding of the online survey; or
- 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.
- Conditions
- Neuroendocrine Tumors
- Medical subject headings
- Neuroendocrine Tumors
What is being measured
The primary outcome is the main question the study is designed to answer.
Attribute importance
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.
Measured: At the end of the survey completion (approximatively 3 months)
Relative attribute importance
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).
Measured: At the end of the survey completion (approximatively 3 months)
Secondary outcomes (2)
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).
Measured: At the end of the survey completion (approximatively 3 months)
Predicted uptake (preference share)
Preference share: Predicted uptake for the different treatments available will be calculated, based on attribute importance..
Measured: At the end of the survey completion (approximatively 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start15 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: Significant and complex challenges had since been identified during recent testing phases. After their assessment, Ipsendecided to discontinue development of this motorized device in order to not burden participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922579
- Sponsor's protocol ID
- CLIN-52030-458
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05922579
- Acronym / sponsor ID
- CLIN-52030-458
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Significant and complex challenges had since been identified during recent testing phases. After their assessment, Ipsendecided to discontinue development of this motorized device in order to not burden participants.
- Enrolment
- 191 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- An interview based on a draft survey: 60-minute interview over videocall, to examine participants understanding of the online survey; or
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (34 listed)
- 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
Key exclusion criteria (1 listed)
- No access to internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Measures of segmentation
Time frame: At the end of the survey completion (approximatively 3 months)
Predicted uptake (preference share)
Time frame: At the end of the survey completion (approximatively 3 months)
Results and safety
The study was stopped early (reason given: Significant and complex challenges had since been identified during recent testing phases. After their assessment, Ipsendecided to discontinue development of this motorized device in order to not burden participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by Ipsen at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Significant and complex challenges had since been identified during recent testing phases. After their assessment, Ipsendecided to discontinue development of this motorized device in order to not burden participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attribute importance (time frame: At the end of the survey completion (approximatively 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.