<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200721048161N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-02</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The role of breast cancer risk assessment in educational intervention based on Health Belief Model for mammography performance in women with family history of breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>The role of breast cancer risk assessment in educational intervention based on Health Belief Model for mammography performance in women with family history of breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>210</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49942</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After preparing the selected samples, individuals will be randomly assigned to three groups (random allocation) to In this way, the names of the people are written on separate sheets and by lottery, the first choice will be assigned to the educational intervention group with the pattern of health belief and risk assessment, the second to the risk assessment group and the third to the control group. It will continue for other people to assign people in groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:In the group of educational intervention with the model of health belief and risk assessment, first using the online program of breast cancer risk assessment based on Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk of the person is estimated and the results are interpreted for the person. Which were based on the structures of the health belief model received. Intervention 2: Intervention group: In individuals in the risk assessment group, using the online breast cancer risk assessment program based on the Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk is estimated and the results are compared based on the percentage of risk of cancer in the next 10 years. With similar people in terms of age and type of risk of cancer (low risk, moderate risk or high risk) based on what is specified in this online program. Intervention 3: Control group: The control group did not receive any training until the end of the study period (after completing the second stage questionnaires).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not made a decision yet. There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Azita Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Salman Farsi St. Bushehr University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 917 772 4605</telephone>
        <email>azitanoroozi@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Azita Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Salman Farsi St. Bushehr University of Medical Sciences</address>
        <city>Bushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 917 772 4605</telephone>
        <email>azitanoroozi@yahoo.com</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women 40 years and older
Having a family history of breast cancer
Not having a mammogram for the past two years
Literacy for reading and writing
Lack of urination and breastfeeding
Willingness to participate in the study
No person has breast cancer or other cancers
Living in Bushehr at the time of the study</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to read the training booklet at the time specified for the participants
Getting pregnant during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:In the group of educational intervention with the model of health belief and risk assessment, first using the online program of breast cancer risk assessment based on Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk of the person is estimated and the results are interpreted for the person. Which were based on the structures of the health belief model received.</i_keyword>
      <i_keyword>Intervention group: In individuals in the risk assessment group, using the online breast cancer risk assessment program based on the Gil model edited by IBIS risk evaluator, the 10-year and lifetime risk is estimated and the results are compared based on the percentage of risk of cancer in the next 10 years. With similar people in terms of age and type of risk of cancer (low risk, moderate risk or high risk) based on what is specified in this online program</i_keyword>
      <i_keyword>Control group: The control group did not receive any training until the end of the study period (after completing the second stage questionnaires).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Doing and not doing mammography. Timepoint: Before training and three months after training. Method of measurement: View mammography answers.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Boushehr University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-18</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>Salman Farsi St. Bushehr University of Medical Sciences Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
