<?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>IRCT2013012512264N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-04</date_registration>
      <primary_sponsor>Vice-Chancellor for Research Deputy in Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Effects of husbands education on meting supportive care needs of breast cancer patients in Tabriz 2013: A clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Effects of husbands education on meting supportive care needs of breast cancer patients in Tabriz 2013: A clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size></target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Three sessions weekly educational intervention will be conducted in 2 hours, in the breast cancer supportive association. First session present by oncologist and one nurse and it’s about physical needs that including pain, lack of energy, nausea, vomiting, sleeping well. second session present by psychologist and one nurse and it’s about psychological needs e.g. anxiety and depression, distress, various concerns in aspects of cancer, fear of spread cancer in body, fear of death, sexual problems and emotional issues and factors effect on breast cancer. Third session it’s about aspects of social, economic and this impact in during illness and discus accessing to health care and counseling with summary of information. Intervention 2: In control group, their husband doesn’t receive any interventions. But at the end of this study they will receive booklet about information .and breast cancer patient just filling the questionnaire.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar Dormitory, Shariati Avenue.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>Nargesmoradi68@yahoo.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farahnaz Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Shariati Avenue.</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1477 0648</telephone>
        <email>Abdollahzadehf@tbzmed.ac.ir</email>
        <affiliation>Nursing and Midwifery Faculty</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria: Diagnosis of breast cancer; Awareness of breast cancer; Have at least 18 years; Married and living with partner.&#13;
Exclusion criteria: Don’t completed the questionnaires at each stage of the study; Don’t participate in training session; Separation or died partner during the study; Recurrence or metastasis during the study.</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z55.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other problems related to education and literacy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Three sessions weekly educational intervention will be conducted in 2 hours, in the breast cancer supportive association. First session present by oncologist and one nurse and it’s about physical needs that including pain, lack of energy, nausea, vomiting, sleeping well. second session present by psychologist and one nurse and it’s about psychological needs e.g. anxiety and depression, distress, various concerns in aspects of cancer, fear of spread cancer in body, fear of death, sexual problems and emotional issues and factors effect on breast cancer. Third session it’s about aspects of social, economic and this impact in during illness and discus accessing to health care and counseling with summary of information.</i_keyword>
      <i_keyword>In control group, their husband doesn’t receive any interventions. But at the end of this study they will receive booklet about information .and breast cancer patient just filling the questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Supportive Care Needs. Timepoint: Before and one month after intervention. Method of measurement: Supportive Care Needs Survey (SCNS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Husband's breast cancer psychoeducation. Timepoint: before and one month after intervention. Method of measurement: Supportive care needs survey.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>Not</sec_id>
        <issuing_authority>Not</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice-Chancellor for Research Deputy in Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-01-21</approval_date>
        <contact_name>Ethics committee in Tabriz University of Medical Sciences</contact_name>
        <contact_address>Tabriz university of medical sciences; Golgasht Avenue. Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
