<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/NCT04506710</url>
  </required_header>
  <id_info>
    <org_study_id>RSCS-L0838</org_study_id>
    <nct_id>NCT04506710</nct_id>
  </id_info>
  <brief_title>Improvement of Communicational Skills Between Health Workers and Oncological Patients During Medical Consultative Conversations</brief_title>
  <official_title>Ways to Improve the Efficiency of Communication Between Health Workers and Oncological Patients During Medical Consultative Conversations: an Observational Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</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 aim of the study is to identify the specific patterns of communication between doctors&#xD;
      and oncological patients during medical consultations and develop recommendations to improve&#xD;
      its effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification the communication techniques used by the doctor in the counseling conversation;</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with low-risk prostate cancer</arm_group_label>
    <description>Histologically confirmed low-risk prostate cancer (PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); tumor stage T2a (low- risk according to the D'Amico scale))</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Audio recording of the counseling conversation</intervention_name>
    <description>The patient will have an audio-recorded counseling conversation. Audio recording will be carried out using a portable recorder ZOOM H2n. The audio recordings of the counseling conversations will be performed by the health workers selected to participate in the study.</description>
    <arm_group_label>Patients with low-risk prostate cancer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males with low-risk prostate cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed prostate cancer;&#xD;
&#xD;
          2. PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); the stage of the tumor T2a (low-&#xD;
             risk according to the D'Amico scale);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure of the recording device;&#xD;
&#xD;
          2. Unsatisfactory audio quality.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fedorovskaya Viktorya</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Linguistics and Intercultural Communication</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dmitry Enikeev, M.D., Ph.D.</last_name>
    <phone>+79670897154</phone>
    <email>dvenikeev@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Taratkin, M.D.</last_name>
    <phone>+79670897154</phone>
    <email>marktaratkin@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute for Urology and Reproductive Health, Sechenov University.</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dmitry Enikeev, M.D., Ph.D</last_name>
      <phone>+7 9670897154</phone>
      <email>enikeev-dv@1msmu.ru</email>
    </contact>
    <contact_backup>
      <last_name>Mark Taratkin, MD</last_name>
      <phone>+7 9670897154</phone>
      <email>marktaratkin@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>I.M. Sechenov First Moscow State Medical University</investigator_affiliation>
    <investigator_full_name>Dmitry Enikeev, MD, PhD</investigator_full_name>
    <investigator_title>Deputy Director for Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT04506710
org study id: RSCS-L0838
nct id: NCT04506710
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to identify the specific patterns of communication between doctors
      and oncological patients during medical consultations and develop recommendations to improve
      its effectiveness.
observational model: Cohort
time perspective: Prospective
measure: Identification the communication techniques used by the doctor in the counseling conversation;
time frame: 1 year
arm group label: Patients with low-risk prostate cancer
description: Histologically confirmed low-risk prostate cancer (PSA up to 10 ng / ml; Gleason (3 + 3) = 6 (ISUP 1); tumor stage T2a (low- risk according to the D'Amico scale))
intervention type: Behavioral
intervention name: Audio recording of the counseling conversation
description: The patient will have an audio-recorded counseling conversation. Audio recording will be carried out using a portable recorder ZOOM H2n. The audio recordings of the counseling conversations will be performed by the health workers selected to participate in the study.
arm group label: Patients with low-risk prostate cancer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fedorovskaya Viktorya
role: Study Director
affiliation: Institute of Linguistics and Intercultural Communication
last name: Dmitry Enikeev, M.D., Ph.D.
phone: +79670897154
email: dvenikeev@gmail.com
last name: Mark Taratkin, M.D.
phone: +79670897154
email: marktaratkin@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: I.M. Sechenov First Moscow State Medical University
investigator full name: Dmitry Enikeev, MD, PhD
investigator title: Deputy Director for Research
mesh term: Prostatic Neoplasms
sharing ipd: No