<?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>IRCT20171224038026N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-27</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of theory–based intervention program on promoting screening behavior of breast cancer in employed women</public_title>
      <acronym></acronym>
      <scientific_title>Design, Implementation and Evaluation of theory–based intervention program on promoting screening behavior of breast cancer in employed women  University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Screening, Randomization description: Participants are unaware of being in the intervention and control group. The names of people will be selected in lottery and will be placed in one of the intervention and control groups, Blinding description: After preparing the plan names so that participants do not understand which of the control or intervention groups, respectively.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Increased screening.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": 3 training sessions for 90 minutes, 2 sessions, 60 minutes workshop, one instruction book, one instructional film, 3 pamphlets, 1 posters, 3 photo clips and e-learning. Intervention 2: "Control group": Distribution of booklets and pamphlets and educational CDs.</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 Decisions should be made at the university's discretion</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mitra dogonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences</address>
        <city>hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 17 3452 1398</telephone>
        <email>dogonchi.mitra@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mitra dogonchi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences</address>
        <city>hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 17 3452 1398</telephone>
        <email>dogonchi.mitra@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having ages 61-20 years
Not having breast cancer
Having the consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>69 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Age less than 20 years
Having breast cancer
discontent to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z12.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for screening for malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": 3 training sessions for 90 minutes, 2 sessions, 60 minutes workshop, one instruction book, one instructional film, 3 pamphlets, 1 posters, 3 photo clips and e-learning</i_keyword>
      <i_keyword>"Control group": Distribution of booklets and pamphlets and educational CDs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Doing behavior Screening. Timepoint: Before the intervention and one month and three months after the intervention. Method of measurement: Report behavior screening Through the questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Screening behavior. Timepoint: Before the intervention one month and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Knowledge. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Perceived sensitivity. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Perceived severity. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Reward. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Response Costs. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Fear. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Self Efficacy. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Response Efficacy. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Treat Appraisal. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Coping Appraisal. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Motivation. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Health Promotion. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Screening Behavior of Breast Cancer. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Social Support Theory. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Emotional Support. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Information Support. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Instrumental Support. Timepoint: Before and one and three months after the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Appasial Support. Timepoint: Before and one and three months after the 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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-12</approval_date>
        <contact_name>Assistance   Research &amp; Technology University of Medical Sciences</contact_name>
        <contact_address>Hamedan, Shahid Fahmida St., Hamedan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
