<?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>IRCT20230510058141N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Determining the Impact of the Health Promotion Program for Women with Breast Cancer on the Quality of Life, Hope and Family Support During Surgery and Chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Determining the Effect of Health Promotion Educational Support Program on the Quality of Life, Hope and Family Support of Women with Breast Cancer in the Stage of Surgery and Chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>304</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Blinding description: In this research, the research participants will include breast cancer patients and will be blinded. In this way, while providing full explanations of the research, the patient will be told that the patient will be placed in one of the two control or intervention groups. It will also be explained that if the patient is placed in the control group, he will receive routine interventions and care. Then informed consent will be obtained.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:The intervention includes the implementation of the health promotion program. This program consists of:Holding at least one training session for 30 minutes to justify the laboratory staff to refer the patient to the medical clinic in order to provide the appointment of the doctor to the patient. Holding at least one training session for 30 minutes to justify the reception staff of the clinic to facilitate the doctor's visit to the patient. Telephone follow-up by making at least 2 phone calls to the patient by the nurse working in the health education nursing clinic according to the defined process up to 48 hours after receiving the pathology answer and answering the patient's questions in the form of telephone consultation to follow up the referral and start the treatment. Development of electronic education by updating the website of Omid Hospital by providing up-to-date scientific content, education through smart phones by making it possible to access up-to-date and scientific educational content by scanning the QR code on the educational content. Development of scientific and up-to-date educational content in the application available in Omid Hospital. Making it possible to access educational content through Bluetooth. Holding a face-to-face training session for 15 minutes for the patient and family on how to access the educational materials available on the Omid Hospital website and training the patient and family on how to receive the educational materials by scanning the QR code. Intervention 2: Control group: Providing routine and usual educational, care and treatment interventions.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Health and treatment centers

Where to obtain:
Applicants can refer to the library of Mashhad College of Nursing and Midwifery located on Ebne Sina Street to receive documents. Or call 05138591511 ext. 253 Mrs. Nowrozi.

How to obtain:
Immediately by visiting the Mashhad Nursing and Midwifery Faculty library in person or online

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samane Raffe</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 5, Saremi 52 Ave., Cheraghchi 17.,  Vakilabad Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178835442</zip>
        <telephone>+98 51 3890 9438</telephone>
        <email>Rafes991@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Heshmati Nabavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Ebne Sina Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>38411538</telephone>
        <email>HeshmatiNf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patient is a new case of breast cancer.
She is a candidate for mastectomy surgery or a candidate for a chemotherapy protocol.
The patient is female.
The patient must be between 25 and 65 years old.
Be an Iranian patient.
The patient should be able to read and write in Persian language.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Does not Agree to Participate in the Research.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:The intervention includes the implementation of the health promotion program. This program consists of:Holding at least one training session for 30 minutes to justify the laboratory staff to refer the patient to the medical clinic in order to provide the appointment of the doctor to the patient. Holding at least one training session for 30 minutes to justify the reception staff of the clinic to facilitate the doctor's visit to the patient. Telephone follow-up by making at least 2 phone calls to the patient by the nurse working in the health education nursing clinic according to the defined process up to 48 hours after receiving the pathology answer and answering the patient's questions in the form of telephone consultation to follow up the referral and start the treatment. Development of electronic education by updating the website of Omid Hospital by providing up-to-date scientific content, education through smart phones by making it possible to access up-to-date and scientific educational content by scanning the QR code on the educational content. Development of scientific and up-to-date educational content in the application available in Omid Hospital. Making it possible to access educational content through Bluetooth. Holding a face-to-face training session for 15 minutes for the patient and family on how to access the educational materials available on the Omid Hospital website and training the patient and family on how to receive the educational materials by scanning the QR code.</i_keyword>
      <i_keyword>Control group: Providing routine and usual educational, care and treatment interventions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score obtained from the  EORCT QLQ30 quality of life questionnaire. Timepoint: In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later. Method of measurement: EORCT quality of life  QLQ c30 questionnaire.</prim_outcome>
      <prim_outcome>Hope: the score obtained from the Hearth Hope Index tool. Timepoint: In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later. Method of measurement: Hearth Hope Index tool.</prim_outcome>
      <prim_outcome>Family support: score obtained from the ICE-FPSQ Perceived Family Support Questionnaire. Timepoint: In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later. Method of measurement: ICE-FPSQ Perceived Family Support 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>2023-02-28</approval_date>
        <contact_name>Research Ethics Committees of School of Nursing &amp; Midwifery; Mashhad University of Medical Sciences</contact_name>
        <contact_address>No. 5,  Ceraghchi 17 St., Saremi 52 Ave., VakilAbad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
