<?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>IRCT20151228025743N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-23</date_registration>
      <primary_sponsor>The University of Tarbiat Modares</primary_sponsor>
      <public_title>Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34443</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: To randomly allocate midwives to randomized quadrilateral blocks, interventional and control groups are used. Thus, blocks AABB, ABAA, ABBA, BABA, BBAA, BAAB are written on 6 cards and since the sample size of 90 midwives is estimated, 23 times randomly extracted from a card of one card and replaced by a replacement method Repeating. The extracted words are followed by a written statement and placed in 90 closed envelopes. Then the midwives are numbered from 1 to 90, and the first envelope, the second envelope, and the second, are divided into individuals.
To randomly assign women to Kabul urban community, randomly assigned quadrilateral blocks are used to intervene and control groups. Thus, blocks AABB, ABAA, ABBA, BABA, BBAA, BAAB are written on 6 cards, and since the sample size is 400 women, 100 times randomly extracted from a card of one card and replaced by a repeat replacement method we do. The letters extracted are followed by a single letter and enclosed in 400 closed envelopes. Then the women are numbered from 1 to 400, and the first envelope, the second envelope, and the second, are divided into individuals, Blinding description: just the participant will be informed about how the people will be placed in the intervention and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Evaluation of educational program based on PRECEDE-PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women of Kabul city community..</hc_freetext>
      <i_freetext>Intervention group:  Implementation of training program for midwives: ‬‬‬‬Designed training programs will be implemented through workshops with 15 participants in 3 groups for 3 days. Training sessions for midwives participating in the intervention group will be held at the Women's Health Center. Educational tools include educational slides, educational posters, moles for breast examination, and practical skills for breast examinations to improve practical skills for midwives. During the implementation of the workshop, interactive and question-and-answer training will take place. A complimentary pamphlet will be provided for them to read on their own. Before the intervention, the questionnaires and the checklist for the first stage of midwifery education will be completed in this section. After completing the training sessions again, the same questionnaires and a checklist of the midwives participating in the workshops will be evaluated.To determine the effectiveness of the Women's Health Support Center, the Focus Group will be discussed in each of the 3 groups of 15 midwives (intervention group).To determine the system efficiency, the Focus Group database will be discussed in each of the 3 groups of 15 midwives (intervention group).Women's Training Stage: This section will be conducted by trained midwives from the first stage. The midwives’ skills of breast examination will be double checked by a breast cancer specialist. Methodology: 400 women aged 20-64 years were selected and randomly assigned to intervention and control groups. In the intervention group 200 women and in the control group, 200 women will be included in the study. The method of women's education in the Focus Group and in the groups of 5 people will be taught and questioned by each trained midwife according to the curriculum. Before the intervention, the educational program of knowledge, belief, performance, health beliefs, self-efficacy and monthly self-report self-examination checklist of the breast were completed in this section (pre-test) and two months after the training again, the same questionnaires were provided to research units Placed and completed (post test). In order to encourage the participation in educational sessions for women, a researcher and midwife responsible for training the contact number and email will be provided to the intervention team for any questions.In relation to both control groups, no training is provided according to the program, and they receive only ordinary general education..</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 After completing the work, I will publish a tutorial guide.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minor Lamiyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, beside to Shariati Hospital, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4673</telephone>
        <email>lamyianm@modares.ac.ir</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minor Lamyian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal Al-Ahmad Highway, next to Shariati Hospital, Tarbiat Modares University</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 4673</telephone>
        <email>lamyianm@modares.ac.ir</email>
        <affiliation>The University of Tarbiat Modares</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Afghanistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Including criteria for first stage (Midwives):1.	 Employed at one of the private and public hospitals in Kabul city. 2.	Have not completed the course before, according to the research unit. 3.	Have a tendency to participate in the project.Including criteria for second stage (Women): 1.	Be Between the ages of 20-64. 2.	Strong tendency to attend a classroom. 3.	Be residents of Kabul. 4.	Do not have breast cancer.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>64 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Exclusion criteria: having one of the types of existing cancers or having pathologic specimens suspected of breast cancer as documented during 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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Implementation of training program for midwives: ‬‬‬‬Designed training programs will be implemented through workshops with 15 participants in 3 groups for 3 days. Training sessions for midwives participating in the intervention group will be held at the Women's Health Center. Educational tools include educational slides, educational posters, moles for breast examination, and practical skills for breast examinations to improve practical skills for midwives. During the implementation of the workshop, interactive and question-and-answer training will take place. A complimentary pamphlet will be provided for them to read on their own. Before the intervention, the questionnaires and the checklist for the first stage of midwifery education will be completed in this section. After completing the training sessions again, the same questionnaires and a checklist of the midwives participating in the workshops will be evaluated.To determine the effectiveness of the Women's Health Support Center, the Focus Group will be discussed in each of the 3 groups of 15 midwives (intervention group).To determine the system efficiency, the Focus Group database will be discussed in each of the 3 groups of 15 midwives (intervention group).Women's Training Stage: This section will be conducted by trained midwives from the first stage. The midwives’ skills of breast examination will be double checked by a breast cancer specialist. Methodology: 400 women aged 20-64 years were selected and randomly assigned to intervention and control groups. In the intervention group 200 women and in the control group, 200 women will be included in the study. The method of women's education in the Focus Group and in the groups of 5 people will be taught and questioned by each trained midwife according to the curriculum. Before the intervention, the educational program of knowledge, belief, performance, health beliefs, self-efficacy and monthly self-report self-examination checklist of the breast were completed in this section (pre-test) and two months after the training again, the same questionnaires were provided to research units Placed and completed (post test). In order to encourage the participation in educational sessions for women, a researcher and midwife responsible for training the contact number and email will be provided to the intervention team for any questions.In relation to both control groups, no training is provided according to the program, and they receive only ordinary general education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining the effect of educational program based on the PRECEDE / PROCEED model on professional skills of midwives and promotion of breast cancer control behavior in women in Kabul city. Timepoint: oct 2018 - APR2019. Method of measurement: The method of data collection in all stages of the study is using the following questionnaires. Researcher-made questionnaire on demographic and fertility variables, Midwifery practical skill checklist, Chmpion standard health questionnaire, Knowledge standard questionnaire, Self-efficacy standard questionnaire, Researcher-made checklist for women self-examination self observation, Self-report self-report self-report form of breast self-examination.</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>The University of Tarbiat Modares</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-19</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University of Medical Sciences</contact_name>
        <contact_address>Tehran, Jalal Al Ahmad highway, Beside to Shariati Hospital, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
