<?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>IRCT20140818018842N28</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of coping skills training on fear of recurrence</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of coping  strategy   training on fear of recurrence  in patient  with Leukemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65362</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Other design features: In this study, after the post-test phase, a follow-up phase is conducted using questionnaires with a gap of one month. Before the training, in order to determine the coping strategies of the participants in the study, the coping strategies questionnaire will be completed by the patients. to be added to the training plan based on The coping strategies training program is designed based on the cognitive-behavioral approach and the theory of Folkman and Lazarus in eight sessions for 90 minutes. In this program, problem solving styles, social support, and dealing with negative emotions are taught. In the first meeting, members are introduced and familiarized, the rules of the group are discussed (participation on time and active presence in the meetings and doing homework outside the group). The second session will discuss the definition of stress and identify its dimensions, the third session will be presented on various coping styles of education. In fact, problem-oriented coping styles (seeking more information about the problem, cognitively changing the structure of the problem), emotion-oriented (dealing with fault-finding behaviors, being nervous and upset, mental preoccupation and fantasizing (and avoidance) include behaviors such as coming to society) is explained. The fourth session of problem-solving skills will be taught, and in this session, things like the five steps of problem-solving (problem definition, accurate analysis of anxiety-provoking situations, list of solutions) will be mentioned. In the fifth session: Dealing with negative emotions by teaching how to control the body and teaching relaxation. In the sixth session, teaching how to use support systems including (how to get emotional support, teaching how to get emotional support, teaching how to get practical support, teaching how to get informational support, recommending to use the help of experts) and teaching self-control in the seventh session which includes things (comparing the characteristics of people with external and internal sources of control, teaching self-control or self-management skills, teaching control of behavior and emotions through role playing in the eighth session, as well as summarizing and concluding the materials and teachings presented in the previous sessions which includes (transferring the experience to real life, evaluation of the course by the participants)..The coping strategies training program is designed based on the cognitive-behavioral approach and the theory of Folk man and Lazarus in eight sessions for 90 minutes. In this program, problem solving styles, social support, and dealing with negative emotions are taught. In the first meeting, members are introduced and familiarized, the rules of the group are discussed (participation on time and active presence in the meetings and doing homework outside the group). The second session will discuss the definition of stress and identify its dimensions, the third session will be presented on various coping styles of education. In fact, problem-oriented coping styles (seeking more information about the problem, cognitively changing the structure of the problem), emotion-oriented (dealing with fault-finding behaviors, being nervous and upset, mental preoccupation and fantasizing (and avoidance) include behaviors such as coming to society) is explained. The fourth session of problem-solving skills will be taught, and in this session, things like the five steps of problem-solving (problem definition, accurate analysis of anxiety-provoking situations, list of solutions) will be mentioned. In the fifth session: Dealing with negative emotions by teaching how to control the body and teaching relaxation. In the sixth session, teaching how to use support systems including (how to get emotional support, teaching how to get emotional support, teaching how to get practical support, teaching how to get informational support, recommending to use the help of experts) and teaching self-control in the seventh session which includes things (comparing the characteristics of people with external and internal sources of control, teaching self-control or self-management skills, teaching control of behavior and emotions through role playing in the eighth session, as well as summarizing and concluding the materials and teachings presented in the previous sessions which includes (transferring the experience to real life, evaluation of the course by the participants).</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic leukemia (C.L.L/C.M.L).</hc_freetext>
      <i_freetext>Intervention 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 In this research, we intend to keep the names of the patients and only the demographic information including (type of cancer, age and gender) described, analyzed and shared in the form of statistical tables.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leyla sharifi Aliabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital , north of Kargar S.T</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>ctu@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Morvarid ilkhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mirdamad S.t , Tabrizian  S.t</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919953969</zip>
        <telephone>+98 21 2225 9115</telephone>
        <email>Milkhani91@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receive diagnosis of chronic cancer(A.M.L)
Awareness of the disease and its conditions
Age between 30 and 45years
higher  than High school diploma
Receive medical treatment
Participating in training sessions and practicing
Proficiency in Persian language</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>More than 45years old
diagnose Other types of cancer
Failure to participate in training sessions
Education less than diploma
Lack of proficiency in Persian language
Failure to receive medical treatment
Lack of knowledge about the disease and its conditions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coping strategy. Timepoint: Pr-test and post-training. Follow-up stage. Method of measurement: Coping Action Preference Questionnaire (COPE) by Carver et al.</prim_outcome>
      <prim_outcome>Fear of relapse. Timepoint: Pr-test and post-training. Follow-up stage. Method of measurement: Questionnaire of fear of recurrence Simard et al.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of recurrence. Timepoint: In the pre-test stage, using Simard's Fear of Recurrence Questionnaire, then receiving 8/ 90-minute sessions of coping strategies training based on Folkman and Lazarus' theory, with an emphasis on teaching problem-solving styles, social support, dealing with negative emotions, again in the post-test stage of this The test is repeated to determine the effectiveness of coping strategies training on this variable. A month later, in the follow-up phase, this test will be performed again to measure the continuity of the training received by the patients. Method of measurement: Simard's Fear of Recurrence Questionnaire.</sec_outcome>
      <sec_outcome>Coping strategies. Timepoint: Pre-test, post-test and follow-up. Method of measurement: cope operations  preference equerry.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-17</approval_date>
        <contact_name>research Ethics commities of research institute for Oncology, Hematology and cell therapy/ tehran un</contact_name>
        <contact_address>13th floor,Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Educationbetween South Flamek and Zarafshan, Simai Iran s.t , Quds town (west), tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
