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/NCT05995483</url>
    </required_header>
    <id_info>
      <org_study_id>ETK00-2022-0030</org_study_id>
      <nct_id>NCT05995483</nct_id>
    </id_info>
    <brief_title>Experimental Study With Pretest/Posttest Groups Which the Intervention Group Have the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day</brief_title>
    <acronym>BreastSelfExam</acronym>
    <official_title>Kendi Kendine Meme Muayenesi Ile İlgili Anımsatıcı Bildirimlerin Meme Kanseri Korkusu ve Sağlık İnançları Üzerine Etkisi/The Effect of Reminder Notifications About Breast Self-Exam on Fear of Breast Cancer and Health Beliefs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eastern Mediterranean University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eastern Mediterranean University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        H0: Among the intervention and control groups of reminder notifications relating to&#xD;
        self-examination&#xD;
  &#xD;
        H01: Average breast cancer fear score and H02: There is no difference in the average score of&#xD;
        breast cancer health beliefs.&#xD;
  &#xD;
        H1: Among the intervention and control groups of reminder notifications relating to&#xD;
        self-examination&#xD;
  &#xD;
        H11: Average breast cancer fear score H12: Breast cancer is different in terms of average&#xD;
        score of health beliefs&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Newly Enrolled Students in the Nursing Programs at Girne American University and Eastern&#xD;
        Mediterranean University Will Participate in This Study as an Experimental Study With a&#xD;
        Pretest/Posttest Control Group. The Students Will Receive the Same Training. Contrary to the&#xD;
        Control Group, the Intervention Group Will Have the System Which Will Send Reminder&#xD;
        Notifications (Via the Web Base) Directing Them to the Website Containing BSE Training, Along&#xD;
        With the Vector Illustration to be Created for the Concurrent Practice Prepared by the&#xD;
        Researcher on the Determined Ideal Day. Users Will Receive a Notification Twice Via the&#xD;
        Website and Email That Includes Re-examination Seven Days Following the End of Their Period.&#xD;
        Depending on the Permission They Grant to Their Phones, Users Will be Able to Access the BSE&#xD;
        Training Materials on the Website by Clicking on the General Reminder Notification or the&#xD;
        Router, Using Their Browsers, and Logging in to Their Accounts. The Data on the Frequency of&#xD;
        BSE With the &quot;Breast Cancer Fear Scale&quot; and &quot;Champion's Health Belief Model Scale&quot; Will be&#xD;
        Collected From the Users at the End of the Three-month Period of Using the Website, Which&#xD;
        Will be Developed in Order to Raise the Chances of Early Diagnosis by Encouraging BSE.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 4, 2023</start_date>
    <completion_date type="Anticipated">September 4, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 4, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the health belief scores on 'Champion Health Belief Model Scale' and 'Breast Cancer Fear Scale' related web based BSE examination notifications in 3 months.</measure>
      <time_frame>3 months</time_frame>
      <description>Measuring the health belief on breast cancer early diagnosis and awareness with web based bse training and notifications using 'Champion Health Belief Model Scale' and 'Breast Cancer Fear Scale'.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">76</enrollment>
    <condition>Breast Self-Examination</condition>
    <condition>Breast Cancer</condition>
    <condition>Nursing Caries</condition>
    <condition>Cancer</condition>
    <condition>Awakening Early</condition>
    <arm_group>
      <arm_group_label>Have access to web based BSE training and notifications</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Have the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Has no intervention during the study</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Only has an powerpoint training og BSE, not knowing about the web base system</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Early Diagnosis on BSE</intervention_name>
      <description>the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day.</description>
      <arm_group_label>Have access to web based BSE training and notifications</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Who is over 18 years old,&#xD;
  &#xD;
            -  Eastern Mediterranean University and Girne American University, newly enrolled female&#xD;
               students in the Nursing Department of the Faculty of Health Sciences&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who do not meet the criteria&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The research is planned to do on female nursing students</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Eastern Mediterranean University &amp; Girne American University</name>
        <address>
          <city>Kyrenia</city>
          <country>Cyprus</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Cyprus</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Awareness</keyword>
    <keyword>Early Diagnosis</keyword>
    <keyword>Prevent Surgery</keyword>
    <keyword>Breast Self-Examination</keyword>
    <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>Yes</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/NCT05995483
  org study id: ETK00-2022-0030
  nct id: NCT05995483
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  H0: Among the intervention and control groups of reminder notifications relating to
        self-examination
  
        H01: Average breast cancer fear score and H02: There is no difference in the average score of
        breast cancer health beliefs.
  
        H1: Among the intervention and control groups of reminder notifications relating to
        self-examination
  
        H11: Average breast cancer fear score H12: Breast cancer is different in terms of average
        score of health beliefs
  Newly Enrolled Students in the Nursing Programs at Girne American University and Eastern
        Mediterranean University Will Participate in This Study as an Experimental Study With a
        Pretest/Posttest Control Group. The Students Will Receive the Same Training. Contrary to the
        Control Group, the Intervention Group Will Have the System Which Will Send Reminder
        Notifications (Via the Web Base) Directing Them to the Website Containing BSE Training, Along
        With the Vector Illustration to be Created for the Concurrent Practice Prepared by the
        Researcher on the Determined Ideal Day. Users Will Receive a Notification Twice Via the
        Website and Email That Includes Re-examination Seven Days Following the End of Their Period.
        Depending on the Permission They Grant to Their Phones, Users Will be Able to Access the BSE
        Training Materials on the Website by Clicking on the General Reminder Notification or the
        Router, Using Their Browsers, and Logging in to Their Accounts. The Data on the Frequency of
        BSE With the "Breast Cancer Fear Scale" and "Champion's Health Belief Model Scale" Will be
        Collected From the Users at the End of the Three-month Period of Using the Website, Which
        Will be Developed in Order to Raise the Chances of Early Diagnosis by Encouraging BSE.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in the health belief scores on 'Champion Health Belief Model Scale' and 'Breast Cancer Fear Scale' related web based BSE examination notifications in 3 months.
  time frame: 3 months
  description: Measuring the health belief on breast cancer early diagnosis and awareness with web based bse training and notifications using 'Champion Health Belief Model Scale' and 'Breast Cancer Fear Scale'.
  arm group label: Have access to web based BSE training and notifications
  arm group type: Experimental
  description: Have the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day.
  arm group label: Has no intervention during the study
  arm group type: No Intervention
  description: Only has an powerpoint training og BSE, not knowing about the web base system
  intervention type: Other
  intervention name: Early Diagnosis on BSE
  description: the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day.
  arm group label: Have access to web based BSE training and notifications
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The research is planned to do on female nursing students
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Cyprus
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: Yes