<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/NCT02996201</url>
  </required_header>
  <id_info>
    <org_study_id>R113-A7084-14-S34</org_study_id>
    <nct_id>NCT02996201</nct_id>
  </id_info>
  <brief_title>Electronic Patient Reporting of Side Effects to Chemotherapy: A Cluster Randomized Controlled Trial</brief_title>
  <official_title>Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine whether the use of breast cancer patients' own&#xD;
      electronic reporting of side effects to chemotherapy in a treatment setting has an impact on&#xD;
      the handling of side effects and on the number of hospitalizations, febrile neutropenia and&#xD;
      dose adjustments. We are using the Patient-Reported Outcomes version of the Common&#xD;
      Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)</measure>
    <time_frame>up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy</measure>
    <time_frame>up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy</measure>
    <time_frame>up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy</measure>
    <time_frame>up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handling of side effects documented in the medical record</measure>
    <time_frame>up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews</measure>
    <time_frame>up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and staff compliance as registerede by the software used</measure>
    <time_frame>up to 18 weeks (November 1, 2015 - January 31, 2017)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Adverse Event</condition>
  <condition>Cancer, Breast</condition>
  <condition>Chemotherapeutic Toxicity</condition>
  <condition>Patient Outcomes Assessments</condition>
  <arm_group>
    <arm_group_label>Electronic reporting of PRO-CTCAE items</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Completion of PRO-CTCAE items before consultation</intervention_name>
    <description>Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy</description>
    <arm_group_label>Electronic reporting of PRO-CTCAE items</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Gender •Female: only female participants are being studied&#xD;
&#xD;
        Minimum age&#xD;
&#xD;
        •18 years&#xD;
&#xD;
        Maximum age •N/A&#xD;
&#xD;
        Accepts Healthy Volunteers&#xD;
&#xD;
        •No&#xD;
&#xD;
        Eligibility Criteria&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Breast cancer patients starting adjuvant chemotherapy in the period November 1, 2015 -&#xD;
             September 1, 2016 in Danish oncology clinics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than six scheduled cycles of chemotherapy&#xD;
&#xD;
          -  Not able to read and understand Danish language&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>October 17, 2017</last_update_submitted>
  <last_update_submitted_qc>October 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Helle Pappot</investigator_full_name>
    <investigator_title>Chief physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02996201
org study id: R113-A7084-14-S34
nct id: NCT02996201
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to determine whether the use of breast cancer patients' own
      electronic reporting of side effects to chemotherapy in a treatment setting has an impact on
      the handling of side effects and on the number of hospitalizations, febrile neutropenia and
      dose adjustments. We are using the Patient-Reported Outcomes version of the Common
      Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side
      effects.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy
time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy
time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy
time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Handling of side effects documented in the medical record
time frame: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
measure: Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews
time frame: up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017
measure: Patient and staff compliance as registerede by the software used
time frame: up to 18 weeks (November 1, 2015 - January 31, 2017)
arm group label: Electronic reporting of PRO-CTCAE items
arm group type: Experimental
description: Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
arm group label: Standard practice
arm group type: No Intervention
intervention type: Other
intervention name: Completion of PRO-CTCAE items before consultation
description: Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
arm group label: Electronic reporting of PRO-CTCAE items
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Helle Pappot
investigator title: Chief physician
mesh term: Breast Neoplasms
sharing ipd: No