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Trial record 91 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

The Patient's Journey - the Time to Final Diagnosis in Patients With SiNET

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ClinicalTrials.gov Identifier: NCT03840720
Recruitment Status : Enrolling by invitation
First Posted : February 15, 2019
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Andreas Hallqvist, Vastra Gotaland Region

Brief 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.

Condition or disease
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


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Patient's Journey - Assessing the Time to Final Diagnosis in Patients With Neuroendocrine Tumors (NET) in Western Sweden
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Initial symptoms [ Time Frame: October 2019 ]
    Mapping of patients initial symptoms and their time points through indepths interviews by design thinking methodology

  2. Health care actions [ Time Frame: October 2019 ]
    Mapping of corresponding health care actions and their time points regarding the investigations of symptoms

  3. 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


Secondary Outcome Measures :
  1. Patients' efforts [ Time Frame: October 2019 ]
    Mapping of actions taken by the patient, trying to be diagnosed correctly, through indepths interviews by design thinking methodology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in Western Sweden, > 18 years of age that has been diagnosed with a small intestinal neuroendocrine tumor during 2016-2018
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not able to read and/or understand Swedish language
  • Dementia/memory loss
  • Performance status >3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03840720


Locations
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Sweden
Dept of Oncology
Gothenburg, Sweden
Sponsors and Collaborators
Vastra Gotaland Region
Novartis
Investigators
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Principal Investigator: Andreas Hallqvist, MD, PhD Dept of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden

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Responsible Party: Andreas Hallqvist, Principal investigator, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03840720     History of Changes
Other Study ID Numbers: PR-1.0
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue