<?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>IRCT20220818055741N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Assessing the effectiveness of two-dimensional QR codes on breast cancer patients' knowledge and satisfaction levels.</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effectiveness of utilizing two-dimensional QR codes on patient cards for breast cancer patients undergoing chemotherapy in enhancing knowledge and satisfaction with self-care education compared to the traditional paper-based method</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68990</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization method: simple randomization
Randomization Unit: Individual
Randomization tool: using SPSS statistical software, Blinding description: Participants, data collectors, and data analyst remain blinded to the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:This group of patients, after the initial introduction to the concept of self-care and the objectives of the program, and after completing the ethical consent form, receive the prepared content for chemotherapy sessions in the form of pamphlets on the hospital's website. They access these pamphlets by scanning the QR codes on their mobile phones. These pamphlets consist of a total of 10 readiness pamphlets for chemotherapy, including education related to the introduction of breast cancer, treatment methods, common side effects of chemotherapy, physical self-care techniques, and nutritional and psychological education. Intervention 2: Control group: This group of patients, After the initial introduction to the concept of self-care and the objectives of the program, and after completing the ethical consent form, this group of patients receives the prepared content for chemotherapy sessions in the form of conventional paper pamphlets available at the hospital. These paper pamphlets consist of a total of 10 readiness pamphlets for chemotherapy, including education related to the introduction of breast cancer, treatment methods, common side effects of chemotherapy, physical self-care techniques, and nutritional and psychological 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic information, all patient education forms and briefing session information, all statistical information, and informed consent forms are ready to be sent.

When:
The data will be ready to send after three months.

To whom:
Researchers, medical center staff, and administrators

Conditions:
Help the patient

Where to obtain:
Send email to shariatmadarih3@mum.ac.ir

How to obtain:
Send an email to shariatmadarih3@mum.ac.ir to mention the research title and introduce the applicant's required files.

Comments:
.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>sareh keshvardoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Omid Hospital, Koh Sangi St., Alandesht Crossroads, Mashhad,IRAN</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176613775</zip>
        <telephone>+98 51 3842 6082</telephone>
        <email>s.keshvardoost69@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanie Shariatmadari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Omid Hospital, Koh Sangi St., Alandesht Crossroads, Mashhad,IRAN</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176613775</zip>
        <telephone>+98 51 3842 6082</telephone>
        <email>shariatmadarih3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Breast cancer patients attending outpatient clinic for health education undergoing chemotherapy
Having  a smartphone as a barcode scanner
Being literate in reading and writing</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:This group of patients, after the initial introduction to the concept of self-care and the objectives of the program, and after completing the ethical consent form, receive the prepared content for chemotherapy sessions in the form of pamphlets on the hospital's website. They access these pamphlets by scanning the QR codes on their mobile phones. These pamphlets consist of a total of 10 readiness pamphlets for chemotherapy, including education related to the introduction of breast cancer, treatment methods, common side effects of chemotherapy, physical self-care techniques, and nutritional and psychological education.</i_keyword>
      <i_keyword>Control group: This group of patients, After the initial introduction to the concept of self-care and the objectives of the program, and after completing the ethical consent form, this group of patients receives the prepared content for chemotherapy sessions in the form of conventional paper pamphlets available at the hospital. These paper pamphlets consist of a total of 10 readiness pamphlets for chemotherapy, including education related to the introduction of breast cancer, treatment methods, common side effects of chemotherapy, physical self-care techniques, and nutritional and psychological education.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of patients' knowledge levels is calculated through the scores obtained from the questionnaire. Measurement of patient satisfaction is assessed through the questions in the questionnaire. Timepoint: Two weeks to one month. Method of measurement: Through the researcher-developed questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-13</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Omid Hospital, El Nadasht Crossroad, Sangi St Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
