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/NCT06021496</url>
    </required_header>
    <id_info>
      <org_study_id>CERVİCAL CANCER</org_study_id>
      <nct_id>NCT06021496</nct_id>
    </id_info>
    <brief_title>The Effect of Face-to-face and Online Health Education on Women's Cervical Cancer Knowledge, Health Beliefs and Screening</brief_title>
    <official_title>The Effect of Two Different Methods of Health Education on Women's HPV Knowledge, Cervical Cancer Health Belief and Screening</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Aim: The aim of this study is to determine the effect of health education given by two&#xD;
        different methods on women's knowledge about HPV, cervical cancer health belief and screening&#xD;
        test.&#xD;
  &#xD;
        Materials and Methods: The study was conducted in a parallel groups design as a single-blind&#xD;
        randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each&#xD;
        volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in&#xD;
        Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale,&#xD;
        Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were&#xD;
        used in the study. In the study, while the control group received standard care, the&#xD;
        face-to-face education group was given health education and brochures through home visits and&#xD;
        a reminder interview over the phone; On the other hand, the online training group was given&#xD;
        health education and a digital brochure via video call and a reminder meeting was held once.&#xD;
        One-way analysis of variance and Kruskal Wallis test were used to compare the data of the&#xD;
        three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and&#xD;
        Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of&#xD;
        variance and Robust ANOVA were used in group and time comparisons.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this randomized controlled trial, participants were assigned to three groups by the block&#xD;
        randomization method and the study was conducted in a single-blind parallel groups design. It&#xD;
        was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July&#xD;
        2023. The eligibility of female participants between the ages of 30-65 to participate in the&#xD;
        study was evaluated by the researcher. The sample size was calculated based on the rate of&#xD;
        cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was&#xD;
        used in the calculation. Taking into account possible data loss, it was decided to add 30%&#xD;
        backup participants. In this context, the sample of the study was calculated as 126&#xD;
        participants, 42 in each group. The patients who volunteered to participate in the study were&#xD;
        examined whether they met the inclusion criteria other than the level of drug compliance.&#xD;
        Written informed consent was obtained from the participants who met the inclusion criteria&#xD;
        and a questionnaire form was applied. Participants were assigned to groups using the block&#xD;
        randomization method. No intervention was made in the control group. At the end of the&#xD;
        following first week, face-to-face and online training was provided with the participants in&#xD;
        the online training group, one-to-one home visits, face-to-face training and video calls.&#xD;
        Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a&#xD;
        second questionnaire was applied to all groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 14, 2023</start_date>
    <completion_date type="Actual">May 15, 2023</completion_date>
    <primary_completion_date type="Actual">March 5, 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>
      <intervention_model_description>randomised control trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single blind study, participants do not know their group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>HPV Knowledge Scale</measure>
      <time_frame>60 days</time_frame>
      <description>HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cervical Cancer and Pap Smear Test Health Belief Model Scale</measure>
      <time_frame>60 days</time_frame>
      <description>Although the scale is graded in a 5-point Likert type, it consists of a total of 35 items. The higher the scores obtained from the scale, the higher the sensitivity, caring and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">126</enrollment>
    <condition>Early Detection of Cancer</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face-to-face training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once.&#xD;
  brochure given</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>face to face health education</intervention_name>
      <description>Face-to-face health education with home visit</description>
      <arm_group_label>Face-to-face training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>online health education</intervention_name>
      <description>online health education with video call</description>
      <arm_group_label>Online training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          The criteria for inclusion in this study are;&#xD;
  &#xD;
            1. Volunteering to participate in the study,&#xD;
  &#xD;
            2. To be between the ages of 30-65,&#xD;
  &#xD;
            3. Being a woman&#xD;
  &#xD;
            4. Being married/having an active sexual life,&#xD;
  &#xD;
            5. Having the technical equipment to make video calls,&#xD;
  &#xD;
            6. To be literate in Turkish,&#xD;
  &#xD;
            7. Not having had an HPV DNA / Pap Smear test in the last 5 years. -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The criteria for not being included in this study are;&#xD;
  &#xD;
            1. Being pregnant or in the postpartum trimester,&#xD;
  &#xD;
            2. Having a family history of cervical cancer,&#xD;
  &#xD;
            3. Having had a hysterectomy operation,&#xD;
  &#xD;
            4. To have received any previous training on cervical cancer,&#xD;
  &#xD;
            5. Having a vaginal infection,&#xD;
  &#xD;
            6. To be vaccinated against HPV (3 doses). -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>intervention for cervical cancer</gender_description>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>merve gökmen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ministry of Health</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Health Sciences</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
      <investigator_full_name>Serpil Özdemir</investigator_full_name>
      <investigator_title>Asisstant Professor</investigator_title>
    </responsible_party>
    <keyword>Cervical Cancer</keyword>
    <keyword>Cervical Cancer Screening</keyword>
    <keyword>Health Education</keyword>
    <keyword>Online Education</keyword>
    <keyword>Home Visit</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Uterine Cervical 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>
  
  
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/NCT06021496
  org study id: CERVİCAL CANCER
  nct id: NCT06021496
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Aim: The aim of this study is to determine the effect of health education given by two
        different methods on women's knowledge about HPV, cervical cancer health belief and screening
        test.
  
        Materials and Methods: The study was conducted in a parallel groups design as a single-blind
        randomized controlled trial. The sample consisted of 126 healthy participants, 42 in each
        volunteer group, who were registered at the Martyr Zafer Çalışkan Family Health Center in
        Ankara between January and July 2023, and met the inclusion criteria. HPV Knowledge scale,
        Cervical Cancer and pap Smear Test Health Belief Model Scale and VAS for self-assessment were
        used in the study. In the study, while the control group received standard care, the
        face-to-face education group was given health education and brochures through home visits and
        a reminder interview over the phone; On the other hand, the online training group was given
        health education and a digital brochure via video call and a reminder meeting was held once.
        One-way analysis of variance and Kruskal Wallis test were used to compare the data of the
        three groups after a two-month follow-up, Tukey and Dunn test for multiple comparisons, and
        Wilcoxon test for in-group comparisons before and after. In addition, two-way analysis of
        variance and Robust ANOVA were used in group and time comparisons.
  In this randomized controlled trial, participants were assigned to three groups by the block
        randomization method and the study was conducted in a single-blind parallel groups design. It
        was carried out at Martyr Zafer Çalışkan Family Health Center between January 2023 and July
        2023. The eligibility of female participants between the ages of 30-65 to participate in the
        study was evaluated by the researcher. The sample size was calculated based on the rate of
        cervical cancer screening test in Kurt and Akyüz's study. G Power 3.1.9.2 package program was
        used in the calculation. Taking into account possible data loss, it was decided to add 30%
        backup participants. In this context, the sample of the study was calculated as 126
        participants, 42 in each group. The patients who volunteered to participate in the study were
        examined whether they met the inclusion criteria other than the level of drug compliance.
        Written informed consent was obtained from the participants who met the inclusion criteria
        and a questionnaire form was applied. Participants were assigned to groups using the block
        randomization method. No intervention was made in the control group. At the end of the
        following first week, face-to-face and online training was provided with the participants in
        the online training group, one-to-one home visits, face-to-face training and video calls.
        Four weeks later, a brief reminder was made by phone call. At the end of eight weeks, a
        second questionnaire was applied to all groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomised control trial
  primary purpose: Other
  masking: Single (Participant)
  masking description: single blind study, participants do not know their group
  measure: HPV Knowledge Scale
  time frame: 60 days
  description: HPV Knowledge Scale consists of 4 sub-dimensions and 33 items. Participants score between 0-33.
  measure: Cervical Cancer and Pap Smear Test Health Belief Model Scale
  time frame: 60 days
  description: Although the scale is graded in a 5-point Likert type, it consists of a total of 35 items. The higher the scores obtained from the scale, the higher the sensitivity, caring and motivation; It means that benefits are perceived high for the perception of benefit, and obstacles are perceived high for the perception of obstacles.
  arm group label: control group
  arm group type: No Intervention
  description: Participants in the control group continued to receive standard cervical cancer screening service of the Ministry of Health. No further intervention was made.
  arm group label: Face-to-face training group
  arm group type: Experimental
  description: In addition to the standard cervical screening service of the Ministry of Health, face-to-face health education through home visits and a reminder by phone call were made once.
  brochure given
  arm group label: Online training group
  arm group type: Experimental
  description: In addition to the standard cervical screening service of the Ministry of Health, online health education via video call and a reminder with a phone call once. A digital brochure was given.
  intervention type: Behavioral
  intervention name: face to face health education
  description: Face-to-face health education with home visit
  arm group label: Face-to-face training group
  intervention type: Behavioral
  intervention name: online health education
  description: online health education with video call
  arm group label: Online training group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: intervention for cervical cancer
  minimum age: 30 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: merve gökmen
  role: Principal Investigator
  affiliation: Ministry of Health
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  investigator full name: Serpil Özdemir
  investigator title: Asisstant Professor
  mesh term: Uterine Cervical Neoplasms
  sharing ipd: No