<?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>IRCT20161126031117N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-08</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>A comparison of the effect of education by compact disc and booklet about breast cancer screening on women's knowledge, breast cancer screening behaviors and health anxiety</public_title>
      <acronym>-</acronym>
      <scientific_title>A comparison of the effect of education by compact disc and booklet about breast cancer screening on women's knowledge, breast cancer screening behaviors and health anxiety in attending women to urban healthcare centers.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>159</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Women attending to three healthcare centers (which selected randomly) that will be selected by the method of systematic random, Randomization description: First of all 10 health centers in Ilam, three centers will be selected randomly (using random numbers). The type of intervention for each center will also be determined randomly (using the random number table) (ie, in each center, which type of intervention (CD or booklet, or without intervention) will be specified randomly. At each center, a list of qualified individuals will be selected and selected among them in a sample systematical method. That is, from 1 to the digit of classes’ interval, one digit will be selected randomly, that is the first sample in this center. Then, the next samples are selected as the interval between the classes. In the absence of access or reluctance to participate in the study, the next women will be selected from the list, Blinding description: In the pre-intervention phase, the researcher will send questionnaires to the samples in all three centers, but in the process of evaluating the outcomes, midwives will be asked to complete the questionnaire.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The compact disk will be taken to 53 eligible Women attending the first center that select randomly. This CD contains comprehensive information on various methods for screening breast cancer which provided by academic Jihad. It's validity approved by 10 specialists of reproductive health, obstetrician and gynecologist, breast surgeon and oncologist. Intervention 2: Intervention group 2: The educational booklet will be taken to 53 eligible Women attending to the second center that select randomly. This booklet contains comprehensive information on various methods for screening breast cancer. It's validity approved by 10 specialists of reproductive health, obstetrician and gynecologist, breast surgeon and oncologist. Intervention 3: Control group: Women of this group will not any intervention during the study. The educational booklet will give them at the end of the study.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
the article about comparing education through compact disc and booklet on breast cancer screening behavior and health anxiety will be published.

When:
one year later

To whom:
policy makers, Managers, healthcare providers, researchers, educators and general population.

Conditions:
Vice-chansellor for research of Mazandaran University of Medical Sciences

Where to obtain:
apply to Vice-chansellor for research of Mazandaran University of Medical Sciences in Moallem Square, Sari, Iran

How to obtain:
apply to Vice-chansellor for research of Mazandaran University of Medical Sciences, refer to research manager of University, study and answer.

Comments:
no comment</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery school, Vesal street, AmirMazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817918479</zip>
        <telephone>+98 11 3336 8918</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Soghra Khani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sexual and Reproductive Health Research Center, Nasibeh Nursing and Midwifery school, Vesal street, AmirMazandarani Boulevard</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 8916</telephone>
        <email>s.khani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All women aged 20 to 70 years
with a minimum level of education about guidance school
having a computer or a CD player for watching compact disc
have not been performed breast exam by a physician during the past year
despite the indication of mammography, haven’t done it.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The inability to understand the questions of a questionnaire.
the inability to answer questions of a questionnaire, such as blindness and deafness; diseases that prevent people from learning and responding, such as Alzheimer's, mental retardation; current or history of breast cancer.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm: Breast, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The compact disk will be taken to 53 eligible Women attending the first center that select randomly. This CD contains comprehensive information on various methods for screening breast cancer which provided by academic Jihad. It's validity approved by 10 specialists of reproductive health, obstetrician and gynecologist, breast surgeon and oncologist.</i_keyword>
      <i_keyword>Intervention group 2: The educational booklet will be taken to 53 eligible Women attending to the second center that select randomly. This booklet contains comprehensive information on various methods for screening breast cancer. It's validity approved by 10 specialists of reproductive health, obstetrician and gynecologist, breast surgeon and oncologist.</i_keyword>
      <i_keyword>Control group: Women of this group will not any intervention during the study. The educational booklet will give them at the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breast cancer screening behavior. Timepoint: Before, one week and  three months after the intervention. Method of measurement: Breast Cancer Screening Knowledge and Behavior questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Women's health anxiety. Timepoint: Before, one week and  three months after the intervention. Method of measurement: Health Anxiety 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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-11</approval_date>
        <contact_name>Ethics Comittee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research of Mazandaran University of Medical Sciences, Moalem Square. Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
