<?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>IRCT20200525047565N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-20</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Extended parallel process model on breast self-examination behavior</public_title>
      <acronym></acronym>
      <scientific_title>The effect of educational program using Extended Parallel Process Model on improving breast cancer self-examination behavior in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48399</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: This study is an educational intervention based on a Extended parallel process model aimed at promoting breast self-examination behavior in women.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Educational intervention based on a Extended parallel process model to promote breast self-examination.</hc_freetext>
      <i_freetext>Intervention 1: The training package is developed using the opinions of health promotion specialists and reproductive health professionals based on EPPM and its presentation is based on the steps recommended in this model.Educational sessions in the intervention group are held in 4 sessions during 1 month and during 60-minute sessions.Thus, every week, on average, 4 ,1-hour sessions are held with the average participation of 7 to 10 people, overall 16 education sessions.Outlines of educational materials are:Breast anatomy, definition of breast cancer and its complications, its causes, introduction of prevention methods and early detection of breast cancer and practical training on the correct method of breast self-examination.In order to better convey and understand the content of educational aids such as anatomical mullage, showing videos using the experiences of people with breast cancer, slides and video projectors that convey the material through lectures and questions and answers are provided. Intervention 2: At the end of the educational interventions, in order to comply with ethical standards and not deprive the control group of care in one session, a summary of training materials and important points for the control group will be given as a lecture within 20 minutes but without using multiple EPPM steps.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participants' data remain confidential to the researcher during the assurance given to them at the beginning of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sharareh jannesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Intersection of Niayesh Highway, Opposite to Rajaee Heart Hospital, Schoole of  Nursing and Midwifery, Tehran, Iran .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>shararehjannesari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shrareh jannesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Street, Intersection of Niayesh Highway, Opposite to Rajaee Heart Hospital, Schoole of Nursing and Midwifery, Tehran, Iran .</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2512</telephone>
        <email>shararehjannesari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be between 20 and 60 years old
Be literate
Breast self-examination is done incorrectly or not at all.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>to be during pregnancy and breastfeeding
Have history of malignant breast tumors.
Have breast diseases and other malignancies.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The training package is developed using the opinions of health promotion specialists and reproductive health professionals based on EPPM and its presentation is based on the steps recommended in this model.Educational sessions in the intervention group are held in 4 sessions during 1 month and during 60-minute sessions.Thus, every week, on average, 4 ,1-hour sessions are held with the average participation of 7 to 10 people, overall 16 education sessions.Outlines of educational materials are:Breast anatomy, definition of breast cancer and its complications, its causes, introduction of prevention methods and early detection of breast cancer and practical training on the correct method of breast self-examination.In order to better convey and understand the content of educational aids such as anatomical mullage, showing videos using the experiences of people with breast cancer, slides and video projectors that convey the material through lectures and questions and answers are provided.</i_keyword>
      <i_keyword>At the end of the educational interventions, in order to comply with ethical standards and not deprive the control group of care in one session, a summary of training materials and important points for the control group will be given as a lecture within 20 minutes but without using multiple EPPM steps.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The average score of perceived threat of  women. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The average score of women's perceived efficiency. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The mean score of women's perceived severity. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The mean score of women's perceived susceptibility. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The mean score of women's perceived response efficacy. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The average score of women's perceived self-efficacy. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</prim_outcome>
      <prim_outcome>The average score of women's performance in breast self-examination. Timepoint: before the start of the intervention, Immediately and two months after educational intervention. Method of measurement: A researcher-made questionnaire based on  Extended  parallel process model.</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>Shahid Beheshti University of Medical Sciences, Tehran, Iran.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-01-03</approval_date>
        <contact_name>Ethics Committee In Research , School of Farmecy , Nurssing ,Midwifery of Shahid Beheshti University</contact_name>
        <contact_address>Valiasr Street, intersection of Niayesh Highway ,Schoole of  Nursing and Midwifery,Tehran, Iran . Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
