<?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>IRCT20250729066677N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-31</date_registration>
      <primary_sponsor>Tarbiat Modares University</primary_sponsor>
      <public_title>Comparison of the Effect of Educational Intervention Based on Lecture-Based Learning with Problem/Case-Based Learning on Knowledge, Attitude, and Practice of Female Students Regarding Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Educational Intervention Based on Lecture-Based Learning (LBL) with Problem/Case-Based Learning (PCBL) on Knowledge, Attitude, and Practice (KAP) of Female Students Regarding Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be selected through Simple Random Sampling. The Student List will be Sorted according to Student ID Numbers, and Using R Software, Participants will be randomly Selected from the First Row to the Last until the Required Sample Size is Reached (120 Samples in the Medical Group and 120 in the Non-Medical Group). Then, the Selected Samples will be randomly Divided into Four Groups: Control 1, Control 2, Intervention 1, and Intervention 2, using the Software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Using the lecture method (LBL), an educational package based on the Fourth Revision Summer 1403 version of the Ministry of Health regarding breast cancer, along with multimedia content, will be delivered to participants in three one-hour sessions over two weeks. The training will be conducted in a hybrid format, combining in-person and virtual methods. The training approach in this group will involve creating a dedicated group on a reputable platform, where the educational objectives will be explained to the students. This group will receive three hours of instruction based on the Ministry of Health’s educational package. The instructor will use multimedia, PowerPoint presentations, educational slides, and motion graphic videos to thoroughly explain topics related to breast cancer prevention, warning signs, risk factors (both controllable and uncontrollable), self-care recommendations for prevention, methods of early detection and screening, clinical breast examination (BSE) by oneself, and mammography. It is expected that students will gain a solid theoretical understanding of these topics throughout the sessions. Intervention 2: Intervention Group 2: Using a combined method (PCBL), the educational package provided by the Ministry of Health, along with multimedia content, will be delivered to participants in three one-hour sessions over two weeks. The training will be conducted in a hybrid format, combining in-person and virtual methods. The approach in this group will involve creating a group on a reputable platform in the first stage, followed by an introductory session where the educational objectives will be explained to the students. Initially, an online group will be established on the "Bale" platform, which facilitates online collaboration, before the start of the theoretical classes. This online group will be used for posing questions related to the educational content to be taught (PBL-based teaching method).The instructor will design 5 to 6 open-ended problems based on the Ministry of Health's educational package, covering aspects such as breast cancer prevention methods, warning signs, risk factors (modifiable and non-modifiable), self-care recommendations for breast cancer prevention, methods of early detection and screening, clinical breast examination (BSE) by oneself, and mammography. Educational materials will also be sent to students before the classes begin. Subsequently, students will engage in discussions and debates. The instructor present in the group will provide guidance, answer questions, and offer additional explanations as needed. In the second stage, after students respond to these questions using the PBL approach, the instructor can identify challenges and weaknesses in student learning, allowing for more targeted and effective explanations. This method not only enhances teaching efficiency but also encourages students to think independently. Following this, the CBL (Case-Based Learning) approach will be employed, using simulated clinical scenarios and cases related to breast cancer. Students will be divided into smaller groups to analyze and discuss each case. During this phase, the instructor will ask more clinical questions regarding the timing and steps of performing BSE, what constitutes an abnormal finding in this examination, and the subsequent diagnostic actions. These questions aim to stimulate critical thinking, encourage immediate responses from students, increase their interest in learning, and generate new questions. Finally, proper practical training on how to perform BSE correctly will be provided. All content will be reviewed and approved by clinical specialists beforehand to ensure scientific accuracy, cultural appropriateness, and alignment with national screening guidelines. Intervention 3: Control group 1: The control group will not receive any intervention. At the end of the session arranged for questionnaire completion, the PorsLine link will be provided to the participants, along with instructions on how to complete the questionnaire. One month after, further explanations regarding the completion process will be given to the participants. At the end of the study, if they are interested, the relevant training will also be provided to this group. Intervention 4: Control group 2: This group will consist of individuals who are regularly engaged with AI tools such as ChatGPT and similar platforms to obtain information. Like Control Group 1, this group will not receive any educational intervention. The questionnaire will be completed by participants before the start of the study and one month later. Subsequently, if they are interested, they will receive the relevant training.</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 There is no additional information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Melika Moeinadini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Alley 55,Jahad Blvd., Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619863355</zip>
        <telephone>+98 34 3272 2218</telephone>
        <email>m.moeinadini@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Tehranian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nasr., Jalal AleAhmad., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8288 3589</telephone>
        <email>tehranian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Registration in One of the Postgraduate Programs
Willingness to Participate in the Study
No Diagnosed Breast Cancer</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Using the lecture method (LBL), an educational package based on the Fourth Revision Summer 1403 version of the Ministry of Health regarding breast cancer, along with multimedia content, will be delivered to participants in three one-hour sessions over two weeks. The training will be conducted in a hybrid format, combining in-person and virtual methods. The training approach in this group will involve creating a dedicated group on a reputable platform, where the educational objectives will be explained to the students. This group will receive three hours of instruction based on the Ministry of Health’s educational package. The instructor will use multimedia, PowerPoint presentations, educational slides, and motion graphic videos to thoroughly explain topics related to breast cancer prevention, warning signs, risk factors (both controllable and uncontrollable), self-care recommendations for prevention, methods of early detection and screening, clinical breast examination (BSE) by oneself, and mammography. It is expected that students will gain a solid theoretical understanding of these topics throughout the sessions.</i_keyword>
      <i_keyword>Intervention Group 2: Using a combined method (PCBL), the educational package provided by the Ministry of Health, along with multimedia content, will be delivered to participants in three one-hour sessions over two weeks. The training will be conducted in a hybrid format, combining in-person and virtual methods. The approach in this group will involve creating a group on a reputable platform in the first stage, followed by an introductory session where the educational objectives will be explained to the students. Initially, an online group will be established on the "Bale" platform, which facilitates online collaboration, before the start of the theoretical classes. This online group will be used for posing questions related to the educational content to be taught (PBL-based teaching method).The instructor will design 5 to 6 open-ended problems based on the Ministry of Health's educational package, covering aspects such as breast cancer prevention methods, warning signs, risk factors (modifiable and non-modifiable), self-care recommendations for breast cancer prevention, methods of early detection and screening, clinical breast examination (BSE) by oneself, and mammography. Educational materials will also be sent to students before the classes begin. Subsequently, students will engage in discussions and debates. The instructor present in the group will provide guidance, answer questions, and offer additional explanations as needed. In the second stage, after students respond to these questions using the PBL approach, the instructor can identify challenges and weaknesses in student learning, allowing for more targeted and effective explanations. This method not only enhances teaching efficiency but also encourages students to think independently. Following this, the CBL (Case-Based Learning) approach will be employed, using simulated clinical scenarios and cases related to breast cancer. Students will be divided into smaller groups to analyze and discuss each case. During this phase, the instructor will ask more clinical questions regarding the timing and steps of performing BSE, what constitutes an abnormal finding in this examination, and the subsequent diagnostic actions. These questions aim to stimulate critical thinking, encourage immediate responses from students, increase their interest in learning, and generate new questions. Finally, proper practical training on how to perform BSE correctly will be provided. All content will be reviewed and approved by clinical specialists beforehand to ensure scientific accuracy, cultural appropriateness, and alignment with national screening guidelines.</i_keyword>
      <i_keyword>Control group 1: The control group will not receive any intervention. At the end of the session arranged for questionnaire completion, the PorsLine link will be provided to the participants, along with instructions on how to complete the questionnaire. One month after, further explanations regarding the completion process will be given to the participants. At the end of the study, if they are interested, the relevant training will also be provided to this group.</i_keyword>
      <i_keyword>Control group 2: This group will consist of individuals who are regularly engaged with AI tools such as ChatGPT and similar platforms to obtain information. Like Control Group 1, this group will not receive any educational intervention. The questionnaire will be completed by participants before the start of the study and one month later. Subsequently, if they are interested, they will receive the relevant training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Knowledge, Attitude and Practice of Breast Cancer. Timepoint: at three-time points: before, immediately after, and one month post-intervention. Method of measurement: a localized, Iran-specific knowledge, attitude and practice (KAP) questionnaire on breast cancer.</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>Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-28</approval_date>
        <contact_name>Ethics committee of Tarbiat Modares University</contact_name>
        <contact_address>No. 4, Alley 55, Jihad Blvd kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
