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/NCT06022900</url>
    </required_header>
    <id_info>
      <org_study_id>BREASTCANCER</org_study_id>
      <nct_id>NCT06022900</nct_id>
    </id_info>
    <brief_title>The Effect of Face-to-face and Online Health Education on the Health Beliefs of Women Aged 40-69 and Their Participation in Screening</brief_title>
    <official_title>The Effect of Two Different Methods of Health Education on Self-Efficacy and Health Beliefs of Mammography and Participation in the Screening Program of 40-69 Age Group Women</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>
        Objective: In this study, it was aimed to determine the effects of health education provided&#xD;
        by two different methods on breast cancer and mammography knowledge self-evaluation status,&#xD;
        perceived mammography benefit and barrier levels, mammography self-efficacy levels and&#xD;
        mammography screening of women aged 40-69 years.&#xD;
  &#xD;
        Materials and Methods: The study was conducted in a parallel group design as a single-blind&#xD;
        randomized controlled trial. The sample consisted of 126 healthy volunteers, 42 in each&#xD;
        group, who were registered to Toprakkale Family Health Center between January and July 2023,&#xD;
        met the inclusion criteria. In the study, 10-unit Visual Analogue Scale, mammography benefit&#xD;
        and obstacle perception sub-dimension of Champion's Health Belief Model Scale and Mammography&#xD;
        Self-Efficacy Scale were used for self-assessment of breast cancer and mammography knowledge.&#xD;
        In the study, while the control group received standard care, the face-to-face education&#xD;
        group was given health education and brochures through home visits, and a reminder interview&#xD;
        was made over the phone. Health education and digital brochures were given to the online&#xD;
        training group via video call, and a reminder meeting was held once. After a two-month&#xD;
        follow-up, One-Way Analysis of Variance and Kruskal Wallis H test were used to compare the&#xD;
        data of the three groups, multiple comparisons were analyzed with Tukey's test and Dunn's&#xD;
        test. Generalized Linear Models were used for group and time comparisons.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was conducted as a parallel group, single-blind randomized controlled trial. The&#xD;
        study was carried out in Osmaniye Province Toprakkale Family Health Center between January -&#xD;
        July 2023. In this study, it was calculated that at least 96 participants should be included&#xD;
        in three groups with effect size d=0.18, 95% power and 0.05 error level. G Power 3.1.9.2&#xD;
        package program was used in the calculation. Considering the possible data loss in the study,&#xD;
        it was decided to add 30% of the participants. In this context, the sample of the study was&#xD;
        determined as 126 participants, 42 in each group. After briefing the women aged 40-69 who&#xD;
        came to the FHC for any reason about the purpose of the study, the researcher invited them to&#xD;
        participate in the study. Subsequently, it examined the inclusion criteria of women who&#xD;
        volunteered to participate in the study. The purpose of the study was explained to the&#xD;
        participants who met the inclusion criteria and Form I was administered to the participants.&#xD;
        In the randomization of the participants, the block randomization method was preferred.&#xD;
        Following the administration of Form I, the participants were assigned to the group in the&#xD;
        block randomization list according to the order of arrival at the FHC. No intervention was&#xD;
        made to the control group during the application process. Participants in the online training&#xD;
        group received online health training and a digital training brochure. Participants in the&#xD;
        face-to-face training group received face-to-face health education through home visits and a&#xD;
        training brochure. Four weeks later, the participants in the online and face-to-face training&#xD;
        groups were given a telephone reminder call. At the end of eight weeks, Form II was&#xD;
        administered to all groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 9, 2023</start_date>
    <completion_date type="Actual">May 26, 2023</completion_date>
    <primary_completion_date type="Actual">April 17, 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>Parallel Assignment randomised control trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single (Participant) single blind study, participants do not know their group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Self-Efficacy Scale for Mammography</measure>
      <time_frame>60 days</time_frame>
      <description>The scale consists of 10 items in 5 likert type. The total score obtained varies between 10 and 50.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Champion's Health Belief Model Scale</measure>
      <time_frame>60 days</time_frame>
      <description>Only two sub-dimensions of the scale were used, namely the perception of benefit related to mammography and the perception of barriers related to mammography. Benefits sub-dimension of the scale consists of 5 items, and barriers sub-dimension consists of 11 items. In the scale, perceived mammography benefits dimension is evaluated between 5 and 25 points, and perceived mammography barriers dimension is evaluated between 11 and 55 points.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">126</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group was receiving standard breast cancer screening program service during the study period. standard care; It is this standard health service applied to the whole country.</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 breast cancer screening program service, the participants in this group were provided with online health education about breast cancer and prevention from breast cancer, and a digital education brochure was given At the end of the fourth week from the day they were assigned to the study, they were called by phone and the participants were reminded in line with the summary information about the importance of screening.</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 breast cancer screening program service, the participants in this group were given face-to-face health education about breast cancer and prevention of breast cancer through home visits, and a training brochure was given. At the end of the fourth week from the day they were assigned to the study, they were called by phone and the participants were reminded in line with the summary information about the importance of screening.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online training group</intervention_name>
      <description>online health education with video call</description>
      <arm_group_label>Online training group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Face-to-face training group</intervention_name>
      <description>Face-to-face health education with home visit</description>
      <arm_group_label>Face-to-face training group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteering to participate in the research,&#xD;
  &#xD;
            -  Being literate in Turkish&#xD;
  &#xD;
            -  Be in the age range of 40-69 years&#xD;
  &#xD;
            -  Being a woman&#xD;
  &#xD;
            -  To have technical equipment to make video calls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have any communication barrier&#xD;
  &#xD;
            -  Being pregnant or in puerperium&#xD;
  &#xD;
            -  Breastfeeding&#xD;
  &#xD;
            -  To have had a mammogram in the last two years&#xD;
  &#xD;
            -  Have had a previous benign breast disease or breast cancer&#xD;
  &#xD;
            -  Having a family history of breast cancer&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>intervention for breast cancer</gender_description>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Health Sciences</name>
        <address>
          <city>Ankara</city>
          <zip>06000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>PhD RN</investigator_title>
    </responsible_party>
    <keyword>Breast Cancer</keyword>
    <keyword>Mammography</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>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>
  
  
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/NCT06022900
  org study id: BREASTCANCER
  nct id: NCT06022900
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Objective: In this study, it was aimed to determine the effects of health education provided
        by two different methods on breast cancer and mammography knowledge self-evaluation status,
        perceived mammography benefit and barrier levels, mammography self-efficacy levels and
        mammography screening of women aged 40-69 years.
  
        Materials and Methods: The study was conducted in a parallel group design as a single-blind
        randomized controlled trial. The sample consisted of 126 healthy volunteers, 42 in each
        group, who were registered to Toprakkale Family Health Center between January and July 2023,
        met the inclusion criteria. In the study, 10-unit Visual Analogue Scale, mammography benefit
        and obstacle perception sub-dimension of Champion's Health Belief Model Scale and Mammography
        Self-Efficacy Scale were used for self-assessment of breast cancer and mammography knowledge.
        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
        was made over the phone. Health education and digital brochures were given to the online
        training group via video call, and a reminder meeting was held once. After a two-month
        follow-up, One-Way Analysis of Variance and Kruskal Wallis H test were used to compare the
        data of the three groups, multiple comparisons were analyzed with Tukey's test and Dunn's
        test. Generalized Linear Models were used for group and time comparisons.
  This study was conducted as a parallel group, single-blind randomized controlled trial. The
        study was carried out in Osmaniye Province Toprakkale Family Health Center between January -
        July 2023. In this study, it was calculated that at least 96 participants should be included
        in three groups with effect size d=0.18, 95% power and 0.05 error level. G Power 3.1.9.2
        package program was used in the calculation. Considering the possible data loss in the study,
        it was decided to add 30% of the participants. In this context, the sample of the study was
        determined as 126 participants, 42 in each group. After briefing the women aged 40-69 who
        came to the FHC for any reason about the purpose of the study, the researcher invited them to
        participate in the study. Subsequently, it examined the inclusion criteria of women who
        volunteered to participate in the study. The purpose of the study was explained to the
        participants who met the inclusion criteria and Form I was administered to the participants.
        In the randomization of the participants, the block randomization method was preferred.
        Following the administration of Form I, the participants were assigned to the group in the
        block randomization list according to the order of arrival at the FHC. No intervention was
        made to the control group during the application process. Participants in the online training
        group received online health training and a digital training brochure. Participants in the
        face-to-face training group received face-to-face health education through home visits and a
        training brochure. Four weeks later, the participants in the online and face-to-face training
        groups were given a telephone reminder call. At the end of eight weeks, Form II was
        administered to all groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment randomised control trial
  primary purpose: Other
  masking: Single (Participant)
  masking description: Single (Participant) single blind study, participants do not know their group
  measure: Self-Efficacy Scale for Mammography
  time frame: 60 days
  description: The scale consists of 10 items in 5 likert type. The total score obtained varies between 10 and 50.
  measure: Champion's Health Belief Model Scale
  time frame: 60 days
  description: Only two sub-dimensions of the scale were used, namely the perception of benefit related to mammography and the perception of barriers related to mammography. Benefits sub-dimension of the scale consists of 5 items, and barriers sub-dimension consists of 11 items. In the scale, perceived mammography benefits dimension is evaluated between 5 and 25 points, and perceived mammography barriers dimension is evaluated between 11 and 55 points.
  arm group label: control group
  arm group type: No Intervention
  description: This group was receiving standard breast cancer screening program service during the study period. standard care; It is this standard health service applied to the whole country.
  arm group label: Online training group
  arm group type: Experimental
  description: In addition to the standard breast cancer screening program service, the participants in this group were provided with online health education about breast cancer and prevention from breast cancer, and a digital education brochure was given At the end of the fourth week from the day they were assigned to the study, they were called by phone and the participants were reminded in line with the summary information about the importance of screening.
  arm group label: Face-to-face training group
  arm group type: Experimental
  description: In addition to the standard breast cancer screening program service, the participants in this group were given face-to-face health education about breast cancer and prevention of breast cancer through home visits, and a training brochure was given. At the end of the fourth week from the day they were assigned to the study, they were called by phone and the participants were reminded in line with the summary information about the importance of screening.
  intervention type: Behavioral
  intervention name: Online training group
  description: online health education with video call
  arm group label: Online training group
  intervention type: Behavioral
  intervention name: Face-to-face training group
  description: Face-to-face health education with home visit
  arm group label: Face-to-face training group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: intervention for breast cancer
  minimum age: 40 Years
  maximum age: 69 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
  investigator full name: Serpil Özdemir
  investigator title: PhD RN
  mesh term: Breast Neoplasms
  sharing ipd: No