<?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>IRCT2013071513998N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-07</date_registration>
      <primary_sponsor>Islamic Azad University, Najafabad branch</primary_sponsor>
      <public_title>Roll of yoga  to improve the quality of life  in breast cancer patients receiving chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Effects of yoga on the quality of life in breast cancer patients undergoing chemotherapy and radiotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13699</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Yoga sessions will run for 8 weeks 75 minute every couple of days. Technique was the yoga asana. The importance of education given stretching muscles, tendons and ligaments  joint, muscle contraction on timely in whole body,  reverse movements, torsion and bending modes, status of balance, breathing and relaxation techniques. Insufficient attention was being for every company that she was able to perform the exercises for health. To ensure of doing yoga by cancer patients undergoing chemotherapy and radiotherapy, gave them home exercise checklist and asked them to do exercise at least twice a day and mark on checklist.  At the start of the next session, after receiving the checklist, the instructional content review and were answered to individual questions. 8 weeks after the intervention, the experimental group patients' quality of life was measured again. Intervention 2: Control group: The control group patients were asked during the investigation 8 weeks; do not use a variety of complementary and alternative therapies such as yoga. During this period, the researcher only to be followed them by a call from (once every two weeks). After 8 weeks, once again invited the control group, and were given questionnaires to complete it. After the last of gathering data, the educational pamphlet in yoga was given to control group, and clients to use yoga and other programs were referred to Omid Mehr Community depended to Center of Prognosis and Treatment of Breast Disease in Syedolshohada (AS) hospital.</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>Faridokht Yazdani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Najafabad Branch, Islamic Azad University,Isfahan,Iran</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 33 1229 1111</telephone>
        <email>faridokht.yazdani@yahoo.com&#13;
f-yazdani@pnu.iaun.ac.ir</email>
        <affiliation>Islamic Azad University, Najafabad Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faridokht  Yazdani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery School, Najafabad Branch, Islamic Azad University, Isfahan, Iran</address>
        <city>Najafabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 33 1229 1111</telephone>
        <email>faridokht.yazdani@yahoo.com</email>
        <affiliation>Administer</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1 - having age between 25 to 65 years, 2 - a consciousness, 3 - ability to communicate and interact appropriately in completing the questionnaire, 4 - Pathological diagnosis of breast cancer, 5 - willingness of patients to participate in study, 6 - Stage I and II breast cancer pathology, 7 - no metastasis or lymphatic metastasis zone, 8 - or complete a simple mastectomy, breast conservation surgery (lumpectomy,quadranetomy), 9 - two to six weeks after completion of chemotherapy and or radiation, 10 - Combination therapy: prescribing two or more chemotherapeutic agents for the treatment of cancer (and other performance enhancing drugs have a synergistic effect). 11 - External beam radiation (teletherapy): The patient has been exposed to radiation producing devices, 12 -  not use other methods of complementary medicine at the time of the study, 13 - more than 2,500 white blood cells per cubic millimeter, 14 - Count  platelets more than 50,000 per cubic millimeter, 15 - temperature less than 38.3 ° C or 101 ° F, 16 -  no signs of infection and bleeding. Exclusion criteria for recurrence, disease duration less than 2 weeks,  disorder comorbidity with other mental disorders, a history of cancer, previous surgery on the breast.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>2013 ICD-1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>•A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Yoga sessions will run for 8 weeks 75 minute every couple of days. Technique was the yoga asana. The importance of education given stretching muscles, tendons and ligaments  joint, muscle contraction on timely in whole body,  reverse movements, torsion and bending modes, status of balance, breathing and relaxation techniques. Insufficient attention was being for every company that she was able to perform the exercises for health. To ensure of doing yoga by cancer patients undergoing chemotherapy and radiotherapy, gave them home exercise checklist and asked them to do exercise at least twice a day and mark on checklist.  At the start of the next session, after receiving the checklist, the instructional content review and were answered to individual questions. 8 weeks after the intervention, the experimental group patients' quality of life was measured again.</i_keyword>
      <i_keyword>Control group: The control group patients were asked during the investigation 8 weeks; do not use a variety of complementary and alternative therapies such as yoga. During this period, the researcher only to be followed them by a call from (once every two weeks). After 8 weeks, once again invited the control group, and were given questionnaires to complete it. After the last of gathering data, the educational pamphlet in yoga was given to control group, and clients to use yoga and other programs were referred to Omid Mehr Community depended to Center of Prognosis and Treatment of Breast Disease in Syedolshohada (AS) hospital.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: 8 weeks after intervention. Method of measurement: questionnaire Organization for Research and Treatment of Cancer Europe EORTC QLQ-C30)); and a standard questionnaire specifically to assess quality of life in breast cancer (EORTC QLQ-BR23);.</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>Islamic Azad University, Najafabad branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-12-31</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Research Department, Isfahan University of Medical Sciences Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
