Neuroendocrine Tumours (NET)PREF-NETNCT04649580
United Kingdom (UK) Patient Preference Study of Somatuline Autogel and Treatment Administration Setting
An observational study of Neuroendocrine Tumours (NET), run by Ipsen at 5 sites in United Kingdom.
Trial summary
The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumours (NET)
- How many people
- 80 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 27 Apr 2021to 5 Jun 2022
- 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: UK patients with NET receiving Somatuline Autogel injections at home
Who may be able to join
- Patients with a diagnosis of GEP-NETs
- Patients on prescribed lanreotide Autogel®;
- Patients who have switched from hospital to homecare administration setting at least 2 months ago
- Patients judged to be on a stable dose; 120mg for tumour control or >1 injection at same dose for symptom control
Who cannot join
- Patients who decline or lack capacity to consent to participate in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
Cardiff and Vale University LHB
Cardiff, CF14 4HH
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8XP
Royal Free London NHS Foundation Trust
London, NW3 2QG
About this study
Official title: A Cross-Sectional Patient-Reported Study To Assess The Patient Preference Of Treatment Administration Setting, Impact On Health-Related Quality Of Life, Work Productivity, Wider Societal Costs And Healthcare Utilisation For Patients With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Prescribed Somatuline® Autogel® In A Homecare Setting and Hospital Setting.
The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL)
- Conditions
- Neuroendocrine Tumours (NET)
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Online Survey | Not described | |
| One-to-one interviews | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient preferences of treatment administration setting (homecare or hospital)
Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital
Measured: Baseline
Secondary outcomes (8)
Demographic characteristics of enrolled patients with GEP-NETs
Age (years); Gender (male, female); Current employment status: full time, part time, unemployed, retired, student, homemaker, unpaid carer)
Measured: Baseline
Clinical characteristics of enrolled patients with GEP-NETs
Disease duration; Duration of homecare administration of lanreotide; Duration of hospital administration of lanreotide
Measured: Baseline
Patient-reported impact on healthcare resource use
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.
Measured: Baseline
Patient-reported impact on wider societal costs
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.
Measured: Baseline
Patient-reported work productivity
Assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) and bespoke questionaire
Measured: Baseline
Description of patient-reported HRQoL
Assessed using bespoke questionnaire a patient-reported opinion on how homecare administration compares to hospital administration (i.e. much worse / somewhat worse / about the same / somewhat better / much better) for the number of administration setting related aspects described in the protocol, as well as choosing the most applicable answer(s) where applicable.)
Measured: Baseline
Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting;
Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.
Measured: 1 month
Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health
Assessed using qualitative interviews which will be conducted over the telephone by an experienced qualitative interviewer. During the interview semi-structured interview guide will be used, based on guidance and feedback from a clinical expert (specialist nurse) and patient expert(s). The interviews will be primarily guided by the questions in the discussion guide; however, participants will be free to direct the conversation to topics they feel are relevant to their experience.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start27 Apr 2021
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Tumours (NET)Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 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
- NCT04649580
- Sponsor's protocol ID
- A-GB-52030-394
- Acronym
- PREF-NET
- Status last verified
- Dec 2024
- First submitted
- 23 Sep 2020
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Patient-Reported Study To Assess The Patient Preference Of Treatment Administration Setting, Impact On Health-Related Quality Of Life, Work Productivity, Wider Societal Costs And Healthcare Utilisation For Patients With Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Prescribed Somatuline® Autogel® In A Homecare Setting and Hospital Setting.
- ClinicalTrials.gov ID
- NCT04649580
- Acronym / sponsor ID
- PREF-NET / A-GB-52030-394
- Conditions
- Neuroendocrine Tumours (NET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 2 Dec 2020 (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.
The aim of the study is to generate real-world evidence to describe the patient experience of administration of Somatuline® Autogel® (lanreotide) in homecare and hospital settings, and the associated impact on healthcare utilisation, societal cost, work productivity and health-related quality of life (HRQoL)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Survey | – | – |
| One-to-one interviews | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK patients with NET receiving Somatuline Autogel injections at home
Key inclusion criteria (4 listed)
- Patients with a diagnosis of GEP-NETs
- Patients on prescribed lanreotide Autogel®;
- Patients who have switched from hospital to homecare administration setting at least 2 months ago
- Patients judged to be on a stable dose; 120mg for tumour control or >1 injection at same dose for symptom control
Key exclusion criteria (1 listed)
- Patients who decline or lack capacity to consent to participate in the study
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
Patient preferences of treatment administration setting (homecare or hospital)
Time frame: Baseline
Survey responses of patient experience of injections at home and compared to responses of patient experience of injections when given in hospital
8 secondary outcomes
Demographic characteristics of enrolled patients with GEP-NETs
Time frame: Baseline
Clinical characteristics of enrolled patients with GEP-NETs
Time frame: Baseline
Patient-reported impact on healthcare resource use
Time frame: Baseline
Patient-reported impact on wider societal costs
Time frame: Baseline
Patient-reported work productivity
Time frame: Baseline
Description of patient-reported HRQoL
Time frame: Baseline
Description of patient experience of taking lanreotide in the hospital and homecare settings and reported benefits/limitations of each setting;
Time frame: 1 month
Description of the impact of the homecare and hospital settings on HRQoL, work productivity, emotional and physical health
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Related InfoLink provided by the sponsor.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumours (NET), run by Ipsen at 5 sites in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient preferences of treatment administration setting (homecare or hospital) (time frame: Baseline). 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 17 Dec 2024.