<?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>IRCT20121015011122N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-14</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>the effect of  problem- based learning on quality of life  and life style</public_title>
      <acronym></acronym>
      <scientific_title>The effect of  problem- based learning on quality of life  and life style of patients with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27969</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples were randomly divided into case and control groups based on random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: this group was trained for five sessions of one to one and a half hours at the time of admission based on a program designed based on problem-solving learning in groups of 4 to 5. The educational content of this study in the general aspect of cancer include: fatigue, nausea and vomiting, pain, painful breathing, sleep disturbances, anorexia, diarrhea and constipation, and economic problems, in the specific aspect of the cancer including symptom scales, sexual function, imagination of the future And mental self-concept in the context of lifestyle, including dimensions of health accountability, physical activity, nutrition, spiritual growth, interpersonal relationships, and stress management . Intervention 2: Control group: no intervention was performed in the control group during the training period in the experimental group.</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 total potential data can be shared after unidentifiable people

When:
Start the access period 3 months after printing the article

To whom:
Researchers working in academic and non-academic institutions

Conditions:
For use as a research tool, as a discussion, use the research method

Where to obtain:
Hossein Feizi, via personal e-mail (h_feyzi65@yahoo.com) and academic email (feizi.h@muk.ac.ir) and Kurdistan, Sanandaj, Medical Sciences University, Nursing and Midwifery Faculty, 08733772638, 09181731736

How to obtain:
Send an email from the contact, receive and check the sent email, answer after a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hossein feizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Medical Sciences, School of Nursing and Midwifery, Kurdestan, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3377 2638</telephone>
        <email>h_feyzi65@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hossein feizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sanandaj University of Medical Sciences, Faculty of Nursing and Midwifery</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6618634683</zip>
        <telephone>+98 87 3377 2638</telephone>
        <email>h_feizi65@yahoo.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age range of between 20 and 63 years
patient cooperation
the completion of the informed consent form, participation in the training program by the participants
absence of a history of chronic disease, drug use, mental illness
theand having appropriate physical conditions</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>63 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Incomplete cooperation of samples
dissatisfaction with the company in the research
severe physical conditions and the history of chronic disease, drug use and mental illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C44.501</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified malignant neoplasm of skin of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: this group was trained for five sessions of one to one and a half hours at the time of admission based on a program designed based on problem-solving learning in groups of 4 to 5. The educational content of this study in the general aspect of cancer include: fatigue, nausea and vomiting, pain, painful breathing, sleep disturbances, anorexia, diarrhea and constipation, and economic problems, in the specific aspect of the cancer including symptom scales, sexual function, imagination of the future And mental self-concept in the context of lifestyle, including dimensions of health accountability, physical activity, nutrition, spiritual growth, interpersonal relationships, and stress management .</i_keyword>
      <i_keyword>Control group: no intervention was performed in the control group during the training period in the experimental group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after the intervention. Method of measurement: Standard Quality of Life Quality Questionnaire, Breast Cancer Quality of Life Quality Questionnaire and Health Promotion Lifestyle Standard 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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-30</approval_date>
        <contact_name>Ethics Committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, School of Nursing and Midwifery, Kordestan, Sanandaj Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
