<?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>IRCT2014042117379N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-25</date_registration>
      <primary_sponsor>Vice chancellor for research,  Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Physical activity of the women with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparing self-efficacy, outcome expectations for promoting the physical activity of the women with breast cancer in two groups with and without educational program</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15994</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The target group in question are the individuals visiting Seyyed Alshohada Hospital and the center for palliative medicine in Isfahan. The population of the target group will be then divided into the control and experimental group (in order to determine the test of the participants on odd days, and in order to determine the control group, the even days are considered.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: The first session is devoted to identifying patients’ need for education in the experimental group, then they receive education during at least 4 educational ninety minute sessions with respect to the barriers of self-efficacy in physical activity, energy management, stress management, lymphedema prevention, and other topics mentioned in the group. The training sessions are presented by PowerPoint and the relevant experts for each topic. The educational activities are intended for the promotion of self-efficacy, brainstorming strategies, verbal persuasion, successor experience, framing question in the group. Intervention 2: There is no special arrangement for the control group, except for normal medical care.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>www.ircmj.com</results_url_link>
      <results_summary>  Introduction: Nowadays women tend to live longer after the diagnosis of breast cancer mainly due to earlier diagnoses and advancements in the treatment of cancers. But, unfortunately, because of the complications of medical treatments, women saved from breast cancer experience a considerable level of disability. One of the complications of such treatments is the avoidance of physical activity. Therefore, the objective of the present study is to conduct a training intervention based on the constructs of self-efficacy and outcome expectations in order to enhance the physical activity of women suffering from breast cancer.&lt;br /&gt;&#13;
Methods and Materials: The present research was a clinical pretest-post test trial with a randomized control group conducted on 70 women with a final diagnosis of breast cancer. The time interval during which the study was done was between March and August 2014. The data collection instruments included: 1. Underlying factors questionnaire, 2. Self-efficacy in physical activity and outcome expectations measurement, and 3. International physical activity questionnaire (IPAQ). The former questionnaire was completed before and one month after the educational intervention, as the latter filled out before and three months after it. After collection, the data were entered into SPSS 20. To analyze the data, statistical tests such as the independent t-test, paired t-test, chi squared, and analysis of co-variance were used.&lt;br /&gt;&#13;
Findings: The average age of the studied individuals was 44.57 (SD=6.5), and the two groups showed no significant difference in terms of underlying factors. A significant increase in the self-efficacy and outcome expectations in the experimental group was observed one month after the training intervention, and the amount of physical activity showed a significant increase three months after the intervention (p0.05, t=-0.22).&lt;br /&gt;&#13;
Conclusion: It seems that health education programs based on the needs analysis of the patients can positively affect their behavioral motivation and performance in physical activities. Given the studied sample size, it is necessary to generalize the results to other interventional groups with caution.&lt;br /&gt;&#13;
         </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>Rahele  Solymani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St,  Health School,  Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 2752</telephone>
        <email>Rahelesolymani@hlth.mui.ac.ir;   Raheel_s59@yahoo.com</email>
        <affiliation>Isfahan  University of Medical  Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rahele Solymani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St, Health school, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 2752</telephone>
        <email>Rahelesolymani@hlth.mui.ac.ir;     raheel_s59@yahoo.com</email>
        <affiliation>Isfahan University of  Medical  Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1. the final diagnosis of breast cancer by a physician.  2. With individual consent and their spouse consent if they are married    3. physician’s written consent to the participation of the educational program. 4. The ability to read and write                                                                                       the exclusion criteria: 1. the therapist’s prescription for a ban on attending the sessions, 2. a lack of desire to participate in the study, 3. the absence for more than one session during the educational sessions, 4. People who are diagnosed with cognitive disorder during the educational intervention</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>c50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>50 Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first session is devoted to identifying patients’ need for education in the experimental group, then they receive education during at least 4 educational ninety minute sessions with respect to the barriers of self-efficacy in physical activity, energy management, stress management, lymphedema prevention, and other topics mentioned in the group. The training sessions are presented by PowerPoint and the relevant experts for each topic. The educational activities are intended for the promotion of self-efficacy, brainstorming strategies, verbal persuasion, successor experience, framing question in the group.</i_keyword>
      <i_keyword>There is no special arrangement for the control group, except for normal medical care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy for physical activity. Timepoint: Before the intervention and one month after it. Method of measurement: The standard self-efficacy questionnaire for physical activity by Bandura.</prim_outcome>
      <prim_outcome>Outcome expectation for physical activity. Timepoint: Before the intervention and one month after it. Method of measurement: the questionnaire tested.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physical activity. Timepoint: Before the intervention and three month after it. Method of measurement: the standard physical activity measurement  questionnaire.</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,  Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-01-08</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jarib St, Health School, Isfahan Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
