<?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>IRCT138806172432N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-27</date_registration>
      <primary_sponsor>Vice Chancellor for research ofShiraz University of Medical Sciences, Shiraz, Iran</primary_sponsor>
      <public_title>The Effect of an Educational  Intervention on Quality of Life after Mastectomy Surgery</public_title>
      <acronym>--</acronym>
      <scientific_title>The Effect of an Educational  Intervention based on Pender's Theory on Quality of Life of Breast Cancer Patients after Mastectomy Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-07-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2146</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: random number table.</study_design>
      <phase>2</phase>
      <hc_freetext>Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Interventional  group:&#13;
The interventional program is carried out through 3 training45 to 60 miniutes sessions in three fields of nutrition, physical activity, and stress management. Thus, the intervention group participants take part in the training program in groups of10 to 15, so that group discussion forums become possible. The educational content included information about the disease, its treatment and complications, diet including healthy nutrition for the treatment process, and recovery including healthy food pyramid and foods that are essential for good health. High-risk foods and their low-risk alternatives in the course of treatment are expressed, as well. In addition, healthy cooking method of different food products is emphasized and necessary training is conducted in this area. Also, sports activities, including healthy physical activity pyramid, were emphasized in order to increase mobility at work and home in everyday life. Recommendations are, too, made about performing the activities that the patients can do. Besides, rehabilitation and recovery exercises, including stretching, isotonic, and isometric exercises, are taught to improve shoulder, scapula, and motor muscles movement in the process of treatment and recovery. Moreover, the patients are trained about and are required to do stress reduction and relaxation techniques, such as diaphragmatic breathing, imagination, and positive thinking, every day. They are also provided with the necessary supports in different fields of the intervention. Furthermore, an educational booklet is prepared and given to the patients. &#13;
During the study period, the researchers followes the patients by phone calls and ensured about their self-monitoring. In case the patients need assistance about other problems, they are trained individually or, if necessary, are referred to a specialist. Intervention 2: Control group: control group just will received the routine care of polyclinic.</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>Azadeh Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazee Square, Zand Street, Hazrate Fateme School Of Nursing and Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4258</telephone>
        <email>amiriea@sums.ac.ir</email>
        <affiliation>School Of Nursing and Midwifery Of Shiraz University of Medical Sciences,</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Moattari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazee Square, Zand Street, Hazrate Fateme School Of Nursing and Midwifery, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>: 7193613119</zip>
        <telephone>+98 71 3647 4252</telephone>
        <email>moattar@yahoo.commoattari@yahoo.com</email>
        <affiliation>School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :aging 25-55 years, passage of 6 months from mastectomy surgery, and not suffering from lymphedema and other malignancies. Exclusion criteria:recurrence of the disease and metastasis to other organs.chemoterapy or  radiotrrapy</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 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 OFBreast -Breast Unspecified Mass</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional  group:&#13;
The interventional program is carried out through 3 training45 to 60 miniutes sessions in three fields of nutrition, physical activity, and stress management. Thus, the intervention group participants take part in the training program in groups of10 to 15, so that group discussion forums become possible. The educational content included information about the disease, its treatment and complications, diet including healthy nutrition for the treatment process, and recovery including healthy food pyramid and foods that are essential for good health. High-risk foods and their low-risk alternatives in the course of treatment are expressed, as well. In addition, healthy cooking method of different food products is emphasized and necessary training is conducted in this area. Also, sports activities, including healthy physical activity pyramid, were emphasized in order to increase mobility at work and home in everyday life. Recommendations are, too, made about performing the activities that the patients can do. Besides, rehabilitation and recovery exercises, including stretching, isotonic, and isometric exercises, are taught to improve shoulder, scapula, and motor muscles movement in the process of treatment and recovery. Moreover, the patients are trained about and are required to do stress reduction and relaxation techniques, such as diaphragmatic breathing, imagination, and positive thinking, every day. They are also provided with the necessary supports in different fields of the intervention. Furthermore, an educational booklet is prepared and given to the patients. &#13;
During the study period, the researchers followes the patients by phone calls and ensured about their self-monitoring. In case the patients need assistance about other problems, they are trained individually or, if necessary, are referred to a specialist.</i_keyword>
      <i_keyword>Control group: control group just will received the routine care of polyclinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and two mounths after intervention. Method of measurement: QLQ-C30 Quastionaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Vice Chancellor for research ofShiraz University of Medical Sciences, Shiraz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2008-05-10</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences,  Shiraz,  Iran</contact_name>
        <contact_address>School of Nursing and Midwifery Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
