<?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>IRCT20241221064120N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigation the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy surgery of breast cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigation the effect of multimodal standard nursing program (MSNP) in lymphedema and self-efficacy after mastectomy surgery of breast cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82006</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients are divided into 2 groups using the time block of 34 people randomly allocated using the Sealed envelope website and the groups are named A and B respectively, so that A group will receive multimodal training and B group will receive routine hospital training. The benefit of this method is that the volume of each block must be determined based on the time of visiting the hospital (block of three). Then the list of blocks is written and numbers are assigned to them, then random numbers between 1 to 6 (for example, 1, 4, 5, etc.) are selected and the numbers are placed in sealed envelopes, and people randomly pick the envelopes and continue until the final sample size is reached.(Odd numbers include the intervention group and even numbers include the control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Lymphedema after Mastectomy in breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients with breast cancer after radical mastectomy referred to Omid and Imam Reza teaching hospitals in Mashhad. Intervention: multifaceted nursing training sessions (physical, psychological and social) in six one-hour sessions over six weeks. Intervention 2: Control group: breast cancer patients after radical mastectomy referred to teaching hospitals in Mashhad, who receive the hospital's routine educational content regarding lymphedema and improving self-efficacy.</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:
The data includes age and gender, the incidence of lymphedema, and the self-efficacy of the intervention group and the control group.

When:
The access period starts six months after the publication of the results

To whom:
People working in academic and scientific institutions as well as people working in industry

Conditions:
People who need data for research and scientific work.

Where to obtain:
Elahe safari
safariel3@mums.ac.ir

How to obtain:
First, they will email me the request and the reason for it, and then after checking and confirming her reasons, the data will be emailed to her.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block 52, Shahid Karimi 4,6 Ave, Shahid Karimi Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9194687367</zip>
        <telephone>+98 51 3726 1230</telephone>
        <email>safariel3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block 52, Shahid Karimi 4,6 Ave, Shahid Karimi Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9194687367</zip>
        <telephone>+98 51 3726 1230</telephone>
        <email>safariel3@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Breast cancer diagnosis
Age between 18 and 60 years
Having radical mastectomy surgery
Two days to three months passed after surgery
No diagnosis of lymphedema
Willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Failure to participate in one or more nursing training program sessions
Musculoskeletal disorders of the upper limbs
Having an infection or wound of the upper limbs
Start chemotherapy and radiotherapy treatment
Failure to complete research questionnaires
Announcing withdrawal from the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postmastectomy lymphedema</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: patients with breast cancer after radical mastectomy referred to Omid and Imam Reza teaching hospitals in Mashhad. Intervention: multifaceted nursing training sessions (physical, psychological and social) in six one-hour sessions over six weeks</i_keyword>
      <i_keyword>Control group: breast cancer patients after radical mastectomy referred to teaching hospitals in Mashhad, who receive the hospital's routine educational content regarding lymphedema and improving self-efficacy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The extent of lymphedema after mastectomy in patients with breast cancer. Timepoint: before the start of the intervention, immediately after its completion (primary) and after two weeks after the end of the intervention (secondary). Method of measurement: Q-DASH (standardized Q-DASH) and arm circumference measurement method (by measuring 10 cm above the wrist and 10 cm above the elbow of both limbs and the difference in arm circumference of the two limbs is more than 2 cm).</prim_outcome>
      <prim_outcome>The level of self-efficacy after mastectomy surgery of patients with breast cancer. Timepoint: before the start of the intervention, immediately after its completion (primary) and after two weeks after the end of the intervention (secondary). Method of measurement: Chronic Disease Self-Efficacy Questionnaire (CDSES).</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>2025-01-21</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Deputy for Research and Technology, Qorashi Building, next to Hoveyzeh Cinema, Daneshgah Ave, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
