<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/NCT04493450</url>
  </required_header>
  <id_info>
    <org_study_id>NEMO</org_study_id>
    <nct_id>NCT04493450</nct_id>
  </id_info>
  <brief_title>NEMO - an App for Side Effect Management in Oncology</brief_title>
  <acronym>NEMO</acronym>
  <official_title>NEMO - an App for Side Effect Management in Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Seufferlein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ulm</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>
      This study investigates the use of digital and standardized documentation by patients of&#xD;
      frequently occurring adverse events in oncological therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is structured as a Phase I and II clinical trial. In phase I, the&#xD;
      feasibility of using a smartphone application to document adverse events that have occurred&#xD;
      during oncological therapies by the patient will be investigated. In phase II we will&#xD;
      investigate whether the use of the smartphone app allows an improvement of patient care by&#xD;
      reducing occurred adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Phase I: Patient acceptance of a new medium of communication</measure>
    <time_frame>6 months</time_frame>
    <description>Acceptance of documentation of occurring side effects of oncological therapies with new communication media</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: Change of occurred adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase II: Doses of chemotherapy</measure>
    <time_frame>6 months</time_frame>
    <description>Maintenance of chemotherapy doses through better adverse event management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: Incidence of adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of treatment-emergent adverse events as assessed by the CTCAE scale</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Cancer Patients</condition>
  <arm_group>
    <arm_group_label>Smartphone-users</arm_group_label>
    <description>Cancer patients who use smartphones</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Documentation of cancer treatment side effects</intervention_name>
    <description>Standardized documentation of occurred side effects</description>
    <arm_group_label>Smartphone-users</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Phase I:&#xD;
&#xD;
        - 30 participants in total non-randomly divided into three age groups (&lt; 55 years, 55-75&#xD;
        years, &gt; 75 years) of 10 people each.&#xD;
&#xD;
        Phase II:&#xD;
&#xD;
        - 36 participants randomly assigned a group of 18 persons (smartphone users, non-smartphone&#xD;
        users)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infusional combination therapy with at least two chemotherapy substances with or&#xD;
             without further targeted therapies&#xD;
&#xD;
          -  combination of at least two immune-checkpoint inhibitors&#xD;
&#xD;
          -  able to read and understand German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be excluded:&#xD;
&#xD;
          -  severe neurological disorders&#xD;
&#xD;
          -  severe psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seufferlein</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ulm</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Seufferlein, Prof. Dr.</last_name>
    <phone>+4973150044501</phone>
    <email>thomas.seufferlein@uniklinik-ulm.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Ulm</investigator_affiliation>
    <investigator_full_name>Thomas Seufferlein</investigator_full_name>
    <investigator_title>Professor, Head of Department</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04493450
org study id: NEMO
nct id: NCT04493450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the use of digital and standardized documentation by patients of
      frequently occurring adverse events in oncological therapies.
This research study is structured as a Phase I and II clinical trial. In phase I, the
      feasibility of using a smartphone application to document adverse events that have occurred
      during oncological therapies by the patient will be investigated. In phase II we will
      investigate whether the use of the smartphone app allows an improvement of patient care by
      reducing occurred adverse events.
observational model: Case-Only
time perspective: Prospective
measure: Phase I: Patient acceptance of a new medium of communication
time frame: 6 months
description: Acceptance of documentation of occurring side effects of oncological therapies with new communication media
measure: Phase II: Change of occurred adverse events
time frame: 6 months
description: Changes of side effects by at least 1 degree according to CTCAE scoring in comparison to the study start
measure: Phase II: Doses of chemotherapy
time frame: 6 months
description: Maintenance of chemotherapy doses through better adverse event management
measure: Phase II: Incidence of adverse events
time frame: 6 months
description: Incidence of treatment-emergent adverse events as assessed by the CTCAE scale
arm group label: Smartphone-users
description: Cancer patients who use smartphones
intervention type: Other
intervention name: Documentation of cancer treatment side effects
description: Standardized documentation of occurred side effects
arm group label: Smartphone-users
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Seufferlein
role: Principal Investigator
affiliation: University Hospital Ulm
last name: Thomas Seufferlein, Prof. Dr.
phone: +4973150044501
email: thomas.seufferlein@uniklinik-ulm.de
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Ulm
investigator full name: Thomas Seufferlein
investigator title: Professor, Head of Department
sharing ipd: Undecided