<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/NCT02223091</url>
  </required_header>
  <id_info>
    <org_study_id>KOKON-109863</org_study_id>
    <nct_id>NCT02223091</nct_id>
  </id_info>
  <brief_title>KOKON Consultation on Complementary Medicine in Oncology - a Pilot Study</brief_title>
  <acronym>KOKON-AS</acronym>
  <official_title>Prospective, Multi-center, Cluster-randomized, Pragmatic, Mixed-method Pilot Study Evaluating a Consultation Training Program for Physicians Within the Framework of KOKON (Competence Network Complementary Medicine in Oncology)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Deutsche Krebshilfe e.V., Bonn (Germany)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the effect of a consultation training program for&#xD;
      physicians on the quality of their consultations of breast cancer patients regarding&#xD;
      complementary medicine. We assume that the training program might enhance the communication&#xD;
      of relevant information, empathy of the physicians or satisfaction with the consultation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of the training program</measure>
    <time_frame>day 1-7</time_frame>
    <description>This is an exploratory study. The main aim is to evaluate the effectiveness of the training program which will be achieved using the different outcome measures defined here as secondary outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge about complementary medicine in oncology and consultations (physicians)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of each consultation session (physicians)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empathy: CARE (patient)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empathy: REM (patient)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Empathy is assessed via an adapted version of the Rating Scales for the Assessment of Empathic Communication in Medical Interviews (REM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the consultation session (patient)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Satisfaction with the consultation session is assessed via questions developed by the study team.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of information (patient)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Quality of the information is assessed via questions developed by the study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative analysis of focus groups (physicians)</measure>
    <time_frame>day 1-7</time_frame>
    <description>Focus groups will be conducted with each group of physicians (trained and untrained). They will be analyzed using qualitative methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative analysis of videotapings of consultation sessions</measure>
    <time_frame>day 1-7</time_frame>
    <description>In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Breast-cancer</condition>
  <arm_group>
    <arm_group_label>Consultation by a trained physician</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The physicians of this group receive a free consultation training program on skills regarding consultations on complementary medicine for breast-cancer patients. The training was developed by a multi-professional team and is comprised of three parts: (1) online-training, (2) on-site-training, and (3) consultation manual. Each of the physicians will counsel 10 patients. The patients in this group therefore receive a consultation by a trained physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Consultation by an untrained physician</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The physicians of the control arm receive no training. Each will counsel 10 patients. The patients in this group therefore receive a consultation by an untrained physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Consultation by a trained physician</intervention_name>
    <arm_group_label>Consultation by a trained physician</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Consultation by an untrained physician</intervention_name>
    <arm_group_label>Consultation by an untrained physician</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for physicians:&#xD;
&#xD;
          -  age &gt;18 years&#xD;
&#xD;
          -  working in a breast center of comprehensive cancer center&#xD;
&#xD;
          -  able to consult 10 patients within working hours&#xD;
&#xD;
          -  training group: able to participate in on-site-training&#xD;
&#xD;
          -  not primarily treating the patients that are consulted&#xD;
&#xD;
          -  good language skills (for consultations)&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  diagnosis of breast-cancer&#xD;
&#xD;
          -  patient in the participating center&#xD;
&#xD;
          -  good language skills (for consultations)&#xD;
&#xD;
          -  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>Claudia M Witt, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brustzentrum am Vivantes Klinikum am Urban</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum im Sana-Klinikum Lichtenberg</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum, Klinik für Gynäkologie, Charité, Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRK Kliniken Westend, Brustzentrum</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg, Brustzentrum</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum der LMU München</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brustzentrum Klinikum Nürnberg-Nord</name>
      <address>
        <city>Nürnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg, Frauenklinik und Poliklinik</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 3, 2015</last_update_submitted>
  <last_update_submitted_qc>August 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Claudia M. Witt</investigator_full_name>
    <investigator_title>Prof. Dr. Claudia M. Witt, MBA</investigator_title>
  </responsible_party>
  <keyword>complementary therapies</keyword>
  <keyword>consultants</keyword>
  <keyword>medical oncology</keyword>
  <keyword>breast-cancer</keyword>
  <keyword>education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT02223091
org study id: KOKON-109863
nct id: NCT02223091
lead sponsor: 
collaborator: 
has dmc: No
The aim of the study is to investigate the effect of a consultation training program for
      physicians on the quality of their consultations of breast cancer patients regarding
      complementary medicine. We assume that the training program might enhance the communication
      of relevant information, empathy of the physicians or satisfaction with the consultation.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Effectiveness of the training program
time frame: day 1-7
description: This is an exploratory study. The main aim is to evaluate the effectiveness of the training program which will be achieved using the different outcome measures defined here as secondary outcome measures.
measure: Knowledge about complementary medicine in oncology and consultations (physicians)
time frame: day 1-7
description: Questions regarding different topics relating to complementary medicine in oncology and consultations of oncology patients
measure: Evaluation of each consultation session (physicians)
time frame: day 1-7
description: Evaluation of the consultation session by the physicians (e.g. time spent on the consultation, difficulties, empathy etc.)
measure: Empathy: CARE (patient)
time frame: day 1-7
description: Empathy is assessed via an adaption of the German version of the Consultation and Relational Empathy scale (CARE)
measure: Empathy: REM (patient)
time frame: day 1-7
description: Empathy is assessed via an adapted version of the Rating Scales for the Assessment of Empathic Communication in Medical Interviews (REM)
measure: Satisfaction with the consultation session (patient)
time frame: day 1-7
description: Satisfaction with the consultation session is assessed via questions developed by the study team.
measure: Quality of information (patient)
time frame: day 1-7
description: Quality of the information is assessed via questions developed by the study team
measure: Qualitative analysis of focus groups (physicians)
time frame: day 1-7
description: Focus groups will be conducted with each group of physicians (trained and untrained). They will be analyzed using qualitative methods.
measure: Qualitative analysis of videotapings of consultation sessions
time frame: day 1-7
description: In each group (consulations by trained and by untrained physicians) 8 consultation sessions will be videotaped and analyzed with qualitative methods.
arm group label: Consultation by a trained physician
arm group type: Experimental
description: The physicians of this group receive a free consultation training program on skills regarding consultations on complementary medicine for breast-cancer patients. The training was developed by a multi-professional team and is comprised of three parts: (1) online-training, (2) on-site-training, and (3) consultation manual. Each of the physicians will counsel 10 patients. The patients in this group therefore receive a consultation by a trained physician.
arm group label: Consultation by an untrained physician
arm group type: Active Comparator
description: The physicians of the control arm receive no training. Each will counsel 10 patients. The patients in this group therefore receive a consultation by an untrained physician.
intervention type: Behavioral
intervention name: Consultation by a trained physician
arm group label: Consultation by a trained physician
intervention type: Behavioral
intervention name: Consultation by an untrained physician
arm group label: Consultation by an untrained physician
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudia M Witt, MD, MBA
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Claudia M. Witt
investigator title: Prof. Dr. Claudia M. Witt, MBA
mesh term: Neoplasms