<?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>IRCT2016060528278N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-28</date_registration>
      <primary_sponsor>Vice Chanellor for Research of Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Effect of psychosexual counselling on the quality of sexual life of women with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effect of psychosexual counselling on the quality of sexual life of women with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22957</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Are randomized in this study using a random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention runs in the plan based on needs assessment and on the basis of sexual schover Administrative Template psychosexual counselling.and checked recent information on past medical history. Askvvr model is merely a tool for qualitative screening is that screening clinical samples. Then, using the FSFI questionnaires and entered the realm of the six samples are screened based on the type of sexual dysfunction DSM5 (ADHD interest / sexual arousal, orgasmic disorders and impaired entry / genital-pelvic pain). Then in the same groups are using this screening tool sub-groups, namely people who have similar sexual dysfunction. In order to impress sexual function, sexual pleasure and sexual quality of life of patients is designed with the content of counseling sessions: the first session (of male and female genitalia and sexual cycle)&#13;
Session II (impact of breast cancer on sexuality)&#13;
Third session (the impact of breast cancer on sexuality)&#13;
Fourth session (interventions)&#13;
 In the four 75-minute sessions. Then there will be follow-up four weeks after the intervention to assess the impact of consultations. In the meantime, a researcher with groups linked via a phone call. At the end of four weeks will test and control groups of sexual quality of life questionnaire, completed function and sexual satisfaction. Intervention 2: The control group will follow after a counseling session.</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>Shakiba Fatehi Abdolmaleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sari Street Salman Farsi streets in paradise Basir first floor apartment unit 2</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3614773955</zip>
        <telephone>+98 11 3336 1994</telephone>
        <email>shakiba.fatehi@shmu.ac.irshakibashakib91@yahoo.comshakibafateh@yahoo.com</email>
        <affiliation>University of Medical Sciences Shahroud</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Mohammad Mirrezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte-Tir Square Shahroud Shahroud University of Medical Sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>mirrezaie78@gmail.com</email>
        <affiliation>University of Medical Sciences Shahroud</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
• a history of breast cancer&#13;
• traverse at least 6 months and a maximum of 3 years from completion of chemotherapy and chemotherapy (except hormonal therapy)&#13;
• Having at least one type of sexual dysfunction using a classification based on the FSFI and DSM5&#13;
• sexually active before cancer&#13;
• No drugs or drug addiction couples&#13;
Excluding criteria:&#13;
• Having heart disease - cardiovascular, diabetes, asthma and other chronic diseases&#13;
• The use of drugs affecting sexual activity&#13;
• history of malignancy other the&#13;
• participation in educational programs, counseling and sex&#13;
• psychological disorders such as depression</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C44.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>C44.5 Skin of trunk</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention runs in the plan based on needs assessment and on the basis of sexual schover Administrative Template psychosexual counselling.and checked recent information on past medical history. Askvvr model is merely a tool for qualitative screening is that screening clinical samples. Then, using the FSFI questionnaires and entered the realm of the six samples are screened based on the type of sexual dysfunction DSM5 (ADHD interest / sexual arousal, orgasmic disorders and impaired entry / genital-pelvic pain). Then in the same groups are using this screening tool sub-groups, namely people who have similar sexual dysfunction. In order to impress sexual function, sexual pleasure and sexual quality of life of patients is designed with the content of counseling sessions: the first session (of male and female genitalia and sexual cycle)&#13;
Session II (impact of breast cancer on sexuality)&#13;
Third session (the impact of breast cancer on sexuality)&#13;
Fourth session (interventions)&#13;
 In the four 75-minute sessions. Then there will be follow-up four weeks after the intervention to assess the impact of consultations. In the meantime, a researcher with groups linked via a phone call. At the end of four weeks will test and control groups of sexual quality of life questionnaire, completed function and sexual satisfaction.</i_keyword>
      <i_keyword>The control group will follow after a counseling session</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual quality of life. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Sexual Quality of Life Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sexual Function. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Sexual Function Questionnaire.</sec_outcome>
      <sec_outcome>Sexual Satisfaction. Timepoint: Before the intervention, one month after the intervention. Method of measurement: Sexual satisfaction questionnaires.</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 Chanellor for Research of Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-29</approval_date>
        <contact_name>Ethics Commitee Of Shahroud  University of Medical Sciences</contact_name>
        <contact_address>Hafte-Tir Square Shahroud Shahroud University of Medical Sciences shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
