Neuroendocrine TumorsNCT03840720
The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET
An observational study of Neuroendocrine Tumors, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
"The patient's journey" is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2019to 31 Dec 2019
- 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: Patients in Western Sweden, > 18 years of age that has been diagnosed with a small intestinal neuroendocrine tumor during 2016-2018
Who may be able to join
- Patients living in Western Sweden
- > 18 years of age
- Performance status 0-3
- Expected remaining survival of > 6 months
- Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018
Who cannot join
- Not able to read and/or understand Swedish language
- Dementia/memory loss
- Performance status >3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden
"The patient's journey" is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.
Read the detailed description
The project focus on patients with small intestinal neuroendocrine tumors (SiNET's) with an incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on "patient's delay" and "doctor's delay" The aim of the current project is to map and analyze the patient's journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process.
The method is interview based and the interviews will be analyzed through the Design Thinking Methodology
- 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.
Initial symptoms
Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology
Measured: October 2019
Health care actions
Mapping of corresponding health care actions and their time points regarding the investigations of symptoms
Measured: October 2019
Reasons for a delayed diagnosis
Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions
Measured: October 2019
Secondary outcomes (1)
Patients' efforts
Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology
Measured: October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Feb 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
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 Vastra Gotaland RegionThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Andreas Hallqvist, Vastra Gotaland Region
- Investigators
- Andreas Hallqvist, MD, PhD, Principal investigator, Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840720
- Sponsor's protocol ID
- PR-1.0
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden
- ClinicalTrials.gov ID
- NCT03840720
- Acronym / sponsor ID
- PR-1.0
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Novartis
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Feb 2019 (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 patient's journey" is an interview based study assessing the patients' experience from the first symptoms to a final diagnosis focusing on patients with small intestinal neuroendocrine tumors.
Detailed description
The project focus on patients with small intestinal neuroendocrine tumors (SiNET's) with an incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and develops gradually over a long time period there is often a long delay from onset to a final diagnosis both depending on "patient's delay" and "doctor's delay" The aim of the current project is to map and analyze the patient's journey from the first appearance of symptoms to the time point of a final diagnosis and to try to identify factors contributing to a delayed process.
The method is interview based and the interviews will be analyzed through the Design Thinking Methodology
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in Western Sweden, > 18 years of age that has been diagnosed with a small intestinal neuroendocrine tumor during 2016-2018
Key inclusion criteria (5 listed)
- Patients living in Western Sweden
- > 18 years of age
- Performance status 0-3
- Expected remaining survival of > 6 months
- Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018
Key exclusion criteria (3 listed)
- Not able to read and/or understand Swedish language
- Dementia/memory loss
- Performance status >3
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
Initial symptoms
Time frame: October 2019
Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology
Health care actions
Time frame: October 2019
Mapping of corresponding health care actions and their time points regarding the investigations of symptoms
Reasons for a delayed diagnosis
Time frame: October 2019
Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions
1 secondary outcome
Patients' efforts
Time frame: October 2019
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 28 Apr 2020.
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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.
Andreas Hallqvist, MD, PhD principal investigator
Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
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 Vastra Gotaland Region at 1 site in Sweden.
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 5 inclusion and 3 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 28 Apr 2020. 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 Sweden. 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?
Initial symptoms (time frame: October 2019). The study lists 3 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 28 Apr 2020.