<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840720</url>
  </required_header>
  <id_info>
    <org_study_id>PR-1.0</org_study_id>
    <nct_id>NCT03840720</nct_id>
  </id_info>
  <brief_title>The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET</brief_title>
  <official_title>The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vastra Gotaland Region</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vastra Gotaland Region</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;The patient's journey&quot; is an interview based study assessing the patients' experience from&#xD;
      the first symptoms to a final diagnosis focusing on patients with small intestinal&#xD;
      neuroendocrine tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project focus on patients with small intestinal neuroendocrine tumors (SiNET's) with an&#xD;
      incidence of 1-2/100 000 yearly. The primary tumor(s) are often small and symptoms usually&#xD;
      arise when the disease has become metastatic with hormonal symptoms and/or symptoms due to&#xD;
      local growth. As the tumors grow slowly and the symptoms in many cases are rather diffuse and&#xD;
      develops gradually over a long time period there is often a long delay from onset to a final&#xD;
      diagnosis both depending on &quot;patient's delay&quot; and &quot;doctor's delay&quot; The aim of the current&#xD;
      project is to map and analyze the patient's journey from the first appearance of symptoms to&#xD;
      the time point of a final diagnosis and to try to identify factors contributing to a delayed&#xD;
      process.&#xD;
&#xD;
      The method is interview based and the interviews will be analyzed through the Design Thinking&#xD;
      Methodology&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Initial symptoms</measure>
    <time_frame>October 2019</time_frame>
    <description>Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health care actions</measure>
    <time_frame>October 2019</time_frame>
    <description>Mapping of corresponding health care actions and their time points regarding the investigations of symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for a delayed diagnosis</measure>
    <time_frame>October 2019</time_frame>
    <description>Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' efforts</measure>
    <time_frame>October 2019</time_frame>
    <description>Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Neuroendocrine Tumors</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in Western Sweden, &gt; 18 years of age that has been diagnosed with a small&#xD;
        intestinal neuroendocrine tumor during 2016-2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients living in Western Sweden&#xD;
&#xD;
          -  &gt; 18 years of age&#xD;
&#xD;
          -  Performance status 0-3&#xD;
&#xD;
          -  Expected remaining survival of &gt; 6 months&#xD;
&#xD;
          -  Diagnosed with a small intestinal neuroendocrine tumor during 2016-2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to read and/or understand Swedish language&#xD;
&#xD;
          -  Dementia/memory loss&#xD;
&#xD;
          -  Performance status &gt;3&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas Hallqvist, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Oncology</name>
      <address>
        <city>Gothenburg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vastra Gotaland Region</investigator_affiliation>
    <investigator_full_name>Andreas Hallqvist</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroendocrine Tumors</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840720
org study id: PR-1.0
nct id: NCT03840720
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"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.
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
observational model: Cohort
time perspective: Cross-Sectional
measure: Initial symptoms
time frame: October 2019
description: Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology
measure: Health care actions
time frame: October 2019
description: Mapping of corresponding health care actions and their time points regarding the investigations of symptoms
measure: Reasons for a delayed diagnosis
time frame: October 2019
description: Mapping of herdles and delays in reaching a final diagnosis through design thinking methodology analysing the patients symptoms and the corresponding Health care actions
measure: Patients' efforts
time frame: October 2019
description: Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Hallqvist, MD, PhD
role: Principal Investigator
affiliation: Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Vastra Gotaland Region
investigator full name: Andreas Hallqvist
investigator title: Principal investigator
mesh term: Neuroendocrine Tumors