<?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>IRCT20250105064279N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-02</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of implementing the family-centered empowerment model on resilience and hope in breast cancer patients referred to diagnostic and treatment centers</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of implementing the family-centered empowerment model on resilience and hope in breast cancer patients referred to diagnostic and treatment centers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>88</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81249</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Initially, 88 breast cancer patients were selected from diagnostic and treatment centers in Ilam, based on the study's inclusion criteria. Subsequently, they were randomly assigned to two groups (intervention and control) using a block randomization method with a block size of 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: : The stages of the family-centered empowerment model are in 4 main steps, respectively, including 1- understanding the threat, 2- promoting self-efficacy/problem solving, 3- promoting self-confidence and self-esteem through educational participation, 4- evaluation will be done during 8 sessions for the intervention group. became . Intervention 2: Control group: Patients in the control group will not be subjected to any intervention in the form of research.</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 potentially identifiable data can be shared after individuals have been anonymized

When:
Access to the data will begin six months after the results are published

To whom:
For all researchers

Conditions:
For use in other research

Where to obtain:
A.raiesifar@gmail.com
You can refer to this email address :masoomehzeraati97mz@gmail.com

How to obtain:
After the completion of the study and the publication of the results, by sending an email to the responsible author, the documentation can be accessed within a maximum of 6 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Zeraati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ilam University of Medical Sciences Pajuhesh Boulevard</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6939177143</zip>
        <telephone>+98 84 3222 7134</telephone>
        <email>masoomehzeraati97mz@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Zeraati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ilam University of Medical Sciences Pajuhesh Boulevard</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6939177143</zip>
        <telephone>+98 84 3222 7134</telephone>
        <email>masoomehzeraati97mz@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definitive diagnosis of cancer by a specialist doctor
Based on clinical findings, cytological studies, and medical diagnosis, the breast cancer is staged at 1-3.
Age between 18 and 65 years
At least 6 months have passed since the breast cancer diagnosis-
Fully conscious and alert
Able to read and write at a basic level
No visual or auditory impairments that significantly affect communication
No history of underlying medical conditions (such as heart attack, stroke, heart failure, acute psychiatric illness, or known psychiatric disorder)
No significant stressful life events, such as the death of a loved one, within the past 6 months(based on patient reports)
Completion of an informed consent form to participate in the study
Living with at least one family member
Not employed as a healthcare provider</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast of unspecified site</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: : The stages of the family-centered empowerment model are in 4 main steps, respectively, including 1- understanding the threat, 2- promoting self-efficacy/problem solving, 3- promoting self-confidence and self-esteem through educational participation, 4- evaluation will be done during 8 sessions for the intervention group. became .</i_keyword>
      <i_keyword>Control group: Patients in the control group will not be subjected to any intervention in the form of research</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: before the intervention - after the intervention and one month after the intervention. Method of measurement: Connor-Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Hope. Timepoint: before the intervention - after the intervention and one month after the intervention. Method of measurement: Miller Hope Scale.</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>Non-communicable diseases research center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-10</approval_date>
        <contact_name>Ethics Committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Banganjab, Ilam University of Medical Sciences, Research and Technology Building ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
