<?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>IRCT20200117046165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-16</date_registration>
      <primary_sponsor>Hakim Sabzevari University</primary_sponsor>
      <public_title>The effect of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of acceptance and commitment group therapy on body image, sexual self-schema and marital intimacy in women with uterine cancer and breast lumpectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45150</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization in this study will be based on a simple random method. Therefore, a random number is assigned to each patient by the table of random numbers, according to which if the number is odd, the patient will be in the intervention group, and if it is an even number, the patient will be in the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Uterine cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Women with uterine cancer and breast lumpectomy surgery will undergo acceptance and commitment group therapy intervention during 8 sessions of 90 minutes (two sessions per week) for 1 months which is based on the acceptance and commitment therapy book of Hayes (1999). The summary of the content of each session is as follows: 1) Introduction and general description of therapeutic approach and explaining the rules and expectations; 2) Assessing patient problems; 3) Elimination of inefficient control of negative events; 4) Separating assessments from personal experiences and observing thoughts without judgment; 5) Contact now and considered self as a context and teaching techniques of mindfulness; 6) Extracting value of patients’ life and evaluation on the basis of their importance; 7) Providing practical solutions to overcome barriers and planning for commitment to pursue the great values of life; 8) A brief description of concepts discussed in each session. Intervention 2: Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Keramati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, Block 8, Pardis residential complex, 2nd Rasti, 26th Adib, Madar Sq., Qasem Abad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9186116616</zip>
        <telephone>+98 51 3621 6117</telephone>
        <email>samira88keramati@gmail.com</email>
        <affiliation>Bojnourd  University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Shareh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hakim Sabzevari University Campus, Tovhid Town</address>
        <city>Mashsad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9617666666</zip>
        <telephone>+98 51 4441 9050</telephone>
        <email>hsharreh@yahoo.com.au</email>
        <affiliation>Hakim Sabzevari University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 21 to 51 years
Having at least a high school diploma
Willingness to participate in the study
Not receiving psychological treatment since diagnosis
Having uterine cancer
Having breast lumpectomy surgery</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>51 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having advanced or metastatic breast cancer
Unwillingness or inability to participate in group psychotherapy sessions
Having other medical and psychiatric disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C53</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of cervix uteri</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Women with uterine cancer and breast lumpectomy surgery will undergo acceptance and commitment group therapy intervention during 8 sessions of 90 minutes (two sessions per week) for 1 months which is based on the acceptance and commitment therapy book of Hayes (1999). The summary of the content of each session is as follows: 1) Introduction and general description of therapeutic approach and explaining the rules and expectations; 2) Assessing patient problems; 3) Elimination of inefficient control of negative events; 4) Separating assessments from personal experiences and observing thoughts without judgment; 5) Contact now and considered self as a context and teaching techniques of mindfulness; 6) Extracting value of patients’ life and evaluation on the basis of their importance; 7) Providing practical solutions to overcome barriers and planning for commitment to pursue the great values of life; 8) A brief description of concepts discussed in each session</i_keyword>
      <i_keyword>Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two training sessions on psychological skills will be provided for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Image Concern. Timepoint: Before the intervention, 30 days after the intervention. Method of measurement: The Littelton Body Image Concern Inventory (2005).</prim_outcome>
      <prim_outcome>Women's Sexual Self-Schema. Timepoint: Before the intervention, 30 days after the intervention. Method of measurement: The Cyranowski women's Sexual Self-Schema Scale (1994).</prim_outcome>
      <prim_outcome>Marital Intimacy. Timepoint: Before the intervention, 30 days after the intervention. Method of measurement: The Bertommen Marital Intimacy Questionnaire (1995).</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>Hakim Sabzevari University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-15</approval_date>
        <contact_name>Ethics committee of Hakim Sabzevari University</contact_name>
        <contact_address>Hakim Sabzevari University Campus, Tovhid Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
