xml: <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/NCT05974787</url>
    </required_header>
    <id_info>
      <org_study_id>10841</org_study_id>
      <nct_id>NCT05974787</nct_id>
    </id_info>
    <brief_title>Potential Improvements Among Cancer Patients in the Pre-emergency Department Care</brief_title>
    <acronym>OVERSEE-I</acronym>
    <official_title>Identification of Potential Improvements Among Cancer Patients and Clinical Staff in the Emergency Department Care Pathway: a Semi-qualitative Study (OVERSEE-I Trial).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        The goal of this single center prospective cross-sectional study is to identify the&#xD;
        facilitators and barriers in the course of the disease that starts when symptoms first arise&#xD;
        until patients with solid and hematologic malignancies arrive in the emergency department&#xD;
        (ED). The main question it aims to answer are: Is there a potential relation between the&#xD;
        lag-time and the ED length of stay (LOS) and the chance of admission. Participants will be&#xD;
        asked to participate in a one-time interview, that focusses on the pre-admission process.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this single center prospective cross-sectional study is to identify the&#xD;
        facilitators and barriers in the course of the disease that starts when symptoms first arise&#xD;
        until patients with solid and hematologic malignancies arrive in the emergency department&#xD;
        (ED). The main question it aims to answer are: Is there a potential relation between the&#xD;
        lag-time and the emergency department length of stay and the chance of admission.&#xD;
        Participants will be asked to participate in a one-time interview, that focusses on the&#xD;
        pre-admission process. The interview focuses on several parts of the (pre-)admission process:&#xD;
        The first part is regarding the timeline that led to an ED visit. The investigators will&#xD;
        establish, when and which symptoms were first detected. The second part are regarding the&#xD;
        number and type of health care workers that were contacted before visiting the ED. The third&#xD;
        part will be about the actions that were taken before the ED visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>Lag-time</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between the first onset of symptoms and a visit to the ED.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Emergency department (ED) length of stay (ED-LOS)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time a patient spends in the ED</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The outcome of a visit to the ED, being either admission or home</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient characteristics</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Age, sex, type of cancer, type of complaint, triage category, number of prior visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between lag-time and ED-LOS</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between lag-time and ED-LOS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between lag-time and disposition</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between lag-time and disposition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between lag-time and patient characteristics</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between lag-time and patient characteristics</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time-to-speak</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between the first notice of symptoms and the first time these complaints were spoken out to the primary giver</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time-to-contact</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between the first time complaints are spoken out and contact is made with a healthcare professional</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time-to-present</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The time between the first contact with a healthcare professional and the presentation at the ED</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in group average lag-time between day, evening and night</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Difference in group average lag-time between day, evening and night</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Willingness to participate</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>the percentage of people that participated in this study in comparison to the people approached for this study.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">175</enrollment>
    <condition>Cancer</condition>
    <condition>Emergencies</condition>
    <arm_group>
      <arm_group_label>Cancer patients</arm_group_label>
      <description>All adult patients with solid and hematologic malignancies and receiving systemic therapy admitted to the emergency department of the Erasmus Medical Center (MC) for the oncology, hematology, lung- and neuro-oncology medical unit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Emergency department cancer patients interview</intervention_name>
      <description>The interview focuses on several parts of the (pre-)admission process: The first part is regarding the timeline that led to an ED visit. The investigators will establish, when and which symptoms were first detected. The second part are regarding the number and type of health care workers that were contacted before visiting the ED. The third part will be about the actions that were taken before the ED visit.</description>
      <arm_group_label>Cancer patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In the emergency department (ED) of Erasmus MC yearly around 1600 patients with cancer are&#xD;
          presented to the ED. To conduct this prospective semi-qualitative trail the principles of&#xD;
          qualitative research and the one in ten rule of statistics were followed. Therefore, the&#xD;
          investigators will conduct interviews with 75 to 175 patients with solid and hematologic&#xD;
          malignancies and receiving systemic therapy admitted to the ED department of the Erasmus MC&#xD;
          for the oncology, hematology, lung- and neuro-oncology medical unit. Furthermore, the&#xD;
          investigators will conduct a parallel interview with the primary caregiver, who lives with&#xD;
          the patient.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with solid and/or hematology malignancies and receiving system therapy&#xD;
  &#xD;
            -  Presented at the emergency department or admitted from the emergency department to the&#xD;
               oncology, hematology or lung-oncology clinical unit&#xD;
  &#xD;
            -  Awake and conscious&#xD;
  &#xD;
            -  Possible to answer questions within 48 hours after presentation in the emergency&#xD;
               department (ED)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years old&#xD;
  &#xD;
            -  Primarily received a surgical intervention as treatment only&#xD;
  &#xD;
            -  Admitted to the ED for the surgical department&#xD;
  &#xD;
            -  Not willing or able to give written informed consent&#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>Jason den Duijn</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jason den Duijn</last_name>
      <phone>+31107040704</phone>
      <email>j.denduijn@erasmusmc.nl</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Jason den Duijn</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>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974787
  org study id: 10841
  nct id: NCT05974787
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this single center prospective cross-sectional study is to identify the
        facilitators and barriers in the course of the disease that starts when symptoms first arise
        until patients with solid and hematologic malignancies arrive in the emergency department
        (ED). The main question it aims to answer are: Is there a potential relation between the
        lag-time and the ED length of stay (LOS) and the chance of admission. Participants will be
        asked to participate in a one-time interview, that focusses on the pre-admission process.
  The goal of this single center prospective cross-sectional study is to identify the
        facilitators and barriers in the course of the disease that starts when symptoms first arise
        until patients with solid and hematologic malignancies arrive in the emergency department
        (ED). The main question it aims to answer are: Is there a potential relation between the
        lag-time and the emergency department length of stay and the chance of admission.
        Participants will be asked to participate in a one-time interview, that focusses on the
        pre-admission process. The interview focuses on several parts of the (pre-)admission process:
        The first part is regarding the timeline that led to an ED visit. The investigators will
        establish, when and which symptoms were first detected. The second part are regarding the
        number and type of health care workers that were contacted before visiting the ED. The third
        part will be about the actions that were taken before the ED visit.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Lag-time
  time frame: Through study completion, an average of 6 months
  description: The time between the first onset of symptoms and a visit to the ED.
  measure: Emergency department (ED) length of stay (ED-LOS)
  time frame: Through study completion, an average of 6 months
  description: The time a patient spends in the ED
  measure: Disposition
  time frame: Through study completion, an average of 6 months
  description: The outcome of a visit to the ED, being either admission or home
  measure: Patient characteristics
  time frame: Through study completion, an average of 6 months
  description: Age, sex, type of cancer, type of complaint, triage category, number of prior visits
  measure: Correlation between lag-time and ED-LOS
  time frame: Through study completion, an average of 6 months
  description: Correlation between lag-time and ED-LOS
  measure: Correlation between lag-time and disposition
  time frame: Through study completion, an average of 6 months
  description: Correlation between lag-time and disposition
  measure: Correlation between lag-time and patient characteristics
  time frame: Through study completion, an average of 6 months
  description: Correlation between lag-time and patient characteristics
  measure: Time-to-speak
  time frame: Through study completion, an average of 6 months
  description: The time between the first notice of symptoms and the first time these complaints were spoken out to the primary giver
  measure: Time-to-contact
  time frame: Through study completion, an average of 6 months
  description: The time between the first time complaints are spoken out and contact is made with a healthcare professional
  measure: Time-to-present
  time frame: Through study completion, an average of 6 months
  description: The time between the first contact with a healthcare professional and the presentation at the ED
  measure: Difference in group average lag-time between day, evening and night
  time frame: Through study completion, an average of 6 months
  description: Difference in group average lag-time between day, evening and night
  measure: Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)
  time frame: Through study completion, an average of 6 months
  description: Difference in group average lag-time between weekdays (Monday 08:00 till Friday 23:59) and weekend (Saturday 00:00 and Monday 7:59)
  measure: Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.
  time frame: Through study completion, an average of 6 months
  description: Correlation between number of contacted healthcare providers before presentation at the ED and the lag- time.
  measure: Willingness to participate
  time frame: Through study completion, an average of 6 months
  description: the percentage of people that participated in this study in comparison to the people approached for this study.
  arm group label: Cancer patients
  description: All adult patients with solid and hematologic malignancies and receiving systemic therapy admitted to the emergency department of the Erasmus Medical Center (MC) for the oncology, hematology, lung- and neuro-oncology medical unit.
  intervention type: Behavioral
  intervention name: Emergency department cancer patients interview
  description: The interview focuses on several parts of the (pre-)admission process: The first part is regarding the timeline that led to an ED visit. The investigators will establish, when and which symptoms were first detected. The second part are regarding the number and type of health care workers that were contacted before visiting the ED. The third part will be about the actions that were taken before the ED visit.
  arm group label: Cancer patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jason den Duijn
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  last name: Jason den Duijn
  phone: +31107040704
  email: j.denduijn@erasmusmc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Jason den Duijn
  investigator title: Principal Investigator
  mesh term: Emergencies
  sharing ipd: No