<?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>IRCT20220122053798N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-28</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of cognitive-behavioral stress management on fear of breast cancer  progression</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive-behavioral stress management on fear of disease progression in women with breast cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61517</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of assigning individuals in control and test groups is random and quadruple blocks (using the table related to random permutations).After determining the volume of blocks, which in this study is 4, a list of blocks is prepared and a number is assigned to them.Then random numbers between 1 and 6 will be selected.(4)AABB(1) , ABAB(2),ABBA(3),BBAA
BABA(5),BAAB(6)
There will be a total of 24 opportunities for random selection.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:For the intervention group (27 people), group stress management training (cognitive-behavioral) is done during 10 weekly sessions. each 90-minute training session will include 45 minutes of training and 45 minutes of practical work Based on Anthony, Ironson, Schneiderman's training package.Behaviorally cognitively stress management is a multifaceted approach in which techniques such as relaxation, diaphragmatic breathing, meditation, detection of negative automatic thoughts, cognitive distortions and its reconstruction by replacing logical thoughts, effective coping training, management Anger and expression are taught to people. Hersbach Fear of disease progression questionnaire is completed in two stages: pre-test and post-test. Intervention 2: Control group:No psychological training is applied for the control group of 27 people, but the questionnaire is administered in two stages of pre-test and post-test and together with the intervention group for the control 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>ّFatemeh Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No14 Sarvenaz  Blvd ,Zibashahr</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7149735416</zip>
        <telephone>+98 71 3273 8397</telephone>
        <email>zare.fatemeh7575@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Khadige Hekmat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz, Golestan Ave, Ahvaz Jundishapur University of Medical Science, Nursing and Midwifery School, Midwifery Department</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3373 8331</telephone>
        <email>hekmat1346@Gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a cancer diagnosis by a specialist
Score above 85 of the Fear of Disease Progression Questionnaire
Be literate
Willingness to participate in research
Written consent to participate in the research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Reluctance to continue participating in research
Incomplete completion of the questionnaire
Having medical disorders at the same time
Under psychotherapy simultaneously
Having serious illnesses or cancer
Having any signs of metastatic disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm  of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:For the intervention group (27 people), group stress management training (cognitive-behavioral) is done during 10 weekly sessions. each 90-minute training session will include 45 minutes of training and 45 minutes of practical work Based on Anthony, Ironson, Schneiderman's training package.Behaviorally cognitively stress management is a multifaceted approach in which techniques such as relaxation, diaphragmatic breathing, meditation, detection of negative automatic thoughts, cognitive distortions and its reconstruction by replacing logical thoughts, effective coping training, management Anger and expression are taught to people. Hersbach Fear of disease progression questionnaire is completed in two stages: pre-test and post-test</i_keyword>
      <i_keyword>Control group:No psychological training is applied for the control group of 27 people, but the questionnaire is administered in two stages of pre-test and post-test and together with the intervention group for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of disease progression score in the fear of disease progression questionnaire of Hersbach. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: fear of disease progression questionnaire of Hersbach.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-15</approval_date>
        <contact_name>Ethics committeee of Ahvaz  University of Medical Sciences</contact_name>
        <contact_address>Ahvaz University of Medical sciences, Golestan Blvd,Ahvaz ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
