<?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>IRCT20190708044157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-08-09</date_registration>
      <primary_sponsor>Boushehr University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the training program on mammography behavior</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Educational Intervention based on Web and Manual on Mammography Use in Women: An Application of Health Belief Model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40686</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: From all the centers, three are selected via simple random sampling, one center as a web-based intervention group and one center as an intervention group receiving booklet and one center as a control group. In the next step, based on the electronic file in the SIB system individuals having inclusion criteria matches the study sample size are selected randomly.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer screening.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the web-based model-based intervention group there is a description of how to access and use the content of the educational content, including: videos, images and educational texts (multimedia) through the site to individuals. The multimedia educational content is based on the health belief model. The educational package is uploaded to the website after compilation and individuals are asked to view the instructions within a maximum of 1 week. After three days the individuals who have not yet visited the website are contacted and encouraged to use the site's content. And for the individuals who have not yet seen the content of the instructions, the will be given an additional three days to receive the instructions. For the intervention groups in the first month, two reminder messages will be sent within two weeks by SMS. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups. Intervention 2: Intervention group: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the intervention group, the (educational) content will be model-based and in the form of a booklet. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups. Intervention 3: Control group: Get routine care. At the end of the training program, the control group will be provided with the educational content.</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 decided yet; The propagation plan is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hemameddin Javadzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>. Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>sh.javadzadeh@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hemameddin Javadzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani, Boushehr</address>
        <city>Boushehr</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7514633341</zip>
        <telephone>+98 77 3345 0084</telephone>
        <email>sh.javadzadeh@bpums.ac.ir</email>
        <affiliation>Boushehr University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Information recorded in Health Care centers
Having reading and writing skills &amp; the ability to communicate verbally
Age 40 and over
Suitable physical conditions to answer questions and participate in the study
having access to the internet and the knowledge to use it
Having computer and smartphone
Inclination to participate in the research
Failure to do mammograms in the last two years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having breast cancer
Pregnancy
Lactation
Having chest disease history
A history of breast cancer in a first degree family
Drop out of the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the web-based model-based intervention group there is a description of how to access and use the content of the educational content, including: videos, images and educational texts (multimedia) through the site to individuals. The multimedia educational content is based on the health belief model. The educational package is uploaded to the website after compilation and individuals are asked to view the instructions within a maximum of 1 week. After three days the individuals who have not yet visited the website are contacted and encouraged to use the site's content. And for the individuals who have not yet seen the content of the instructions, the will be given an additional three days to receive the instructions. For the intervention groups in the first month, two reminder messages will be sent within two weeks by SMS. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups.</i_keyword>
      <i_keyword>Intervention group: After extracting the names of women aged 40 years and over, the electronic records are reviewed to evaluate some of the criteria for entering the study. For the intervention group, the (educational) content will be model-based and in the form of a booklet. Before and up to two months after the training program, the questionnaires will be completed for each of the three groups.</i_keyword>
      <i_keyword>Control group: Get routine care. At the end of the training program, the control group will be provided with the educational content.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breast cancer screening behavior. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Awareness. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived Benefits. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived Barriers. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived Susceptibility. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Perceived Severity. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Health Motivation. Timepoint: Before intervention and two months after intervention. Method of measurement: Questionnaire.</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>2019-07-24</approval_date>
        <contact_name>Ethics Committee of Bushehr University of Medical Sciences</contact_name>
        <contact_address>. Boushehr University of medical sciences and health services,Salman Farsi St.Bahmani,Bushehr , Bushehr Boushehr Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
