<?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>IRCT20221113056486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-26</date_registration>
      <primary_sponsor>Islamic Azad University, Roudehen branch</primary_sponsor>
      <public_title>Improving resilience and life expectancy and reducing death anxiety in cancer patients</public_title>
      <acronym>درمان مبتنی بر پذیرش و تعهد ( ACT ) _ درمان شناختی - رفتاری ( CBT )</acronym>
      <scientific_title>Comparison of the effectiveness of acceptance and commitment  based therapy and Cognitive - behavioral on anxiety , resilience and life expectancy in Breast Cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66967</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The clinical trial is completed with two intervention and control groups, simple randomized, each group of 15 participants, Randomization description: The sampling method in this research will be voluntary sampling method. At first, 45 people are randomly selected from the volunteers and given a characteristic code using a random number table and placed inside the envelopes and given to me and given to them. 15 people will be divided into three (acceptance and acceptance treatment group, behavioral treatment group, and control group).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Treatment based on acceptance and commitment is held in the form of eight ninety-minute group sessions by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be taken from the participants to check the effectiveness.The content of treatment intervention sessions based on acceptance and commitment includes the following: First session: introduction, stating the basic concepts of treatment, obtaining informed consent, taking a pre-test and examining people's attitudes about unpleasant thoughts and feelings, acceptance and committed action using metaphors and homework.The second session: reviewing past sessions and practicing contact with the present, paying attention to awareness, wanting instead of avoiding, practicing conscious breathing, practicing wanting instead of avoiding using metaphors. Third session: reviewing past sessions, paying attention to awareness and the mental functions of breaking through using metaphors, homework.The fourth session: review of the previous session, examination of values and committed action, examination of obstacles to conduct behavior consistent with values using metaphors and homework.The fifth session: reviewing the previous session, paying attention to awareness and self as a context, identifying the internal obstacles of a valuable life using metaphor, homework.Sixth session: Examining past sessions, paying attention to awareness, making mistakes, breaking grammatical rules using metaphors, homework.The seventh session: stability of the results and review of exercises of the previous session.Eighth session: summing up the sessions and encouraging the participants to continue the exercises after finishing the sessions and treatment, announcing the end of the sessions and taking the post-test. Intervention 2: Intervention group 2: cognitive-behavioral therapy in the form of eight ninety-minute group sessions held by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be conducted to check the effectiveness of the participants.The content of cognitive-behavioral intervention sessions is as follows : First session: Introducing and explaining the basic concepts of treatment and recipes and taking the pre-test and explaining the physiological, cognitive, behavioral processes, homework.The second session: review of the previous session, getting to know your own thoughts, cognitive distortions, identifying them in your thinking, recognizing resistance to treatment and designing strategies to deal with it and homework.The third session: reviewing the previous session, getting to know the foundations of behavioral consequences, teaching the nature of schemas, the relationship between schemas and spontaneous thoughts, and identifying schemas through the vertical arrow and homework.The fourth session: review of the previous session, work on the vertical arrow and solve the problems that the research participants have in using the vertical arrow in order to identify their negative schema and homework.The fifth session: review of the previous session, getting the participants a clearer picture of how the negative beliefs are connected and compatible with each other, organizing the list of negative beliefs and homework.Sixth session: review of the previous session, acceptance of the fact that beliefs can be changed and it is possible that people can revise their beliefs and homework.Seventh session: review of the previous session, understanding that beliefs are different in terms of usefulness and they can be evaluated based on criteria and homework.Eighth session: reviewing the previous session, learning the application of logical analysis about their beliefs, participants' achievement of the concept of opposing belief and announcing the end of the sessions and taking the post-test. Intervention 3: Control group 3: general explanation of research objectives and obtaining informed consent and then conducting a pre-test, while the control group does not receive any intervention, and after two months, a post-test is also taken from 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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pegah Farrokhzad, Mohammad Ebrahim Sarichlou, Hossein Ebrahimi Moghadam, Mahdieh Sadeghpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen - University complex - Islamic Azad University, Roudhen branch</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۷۳۱۸۸۹۸۱</zip>
        <telephone>+98 21 7650 5894</telephone>
        <email>sadeghpoormahdieh@yahoo.com</email>
        <affiliation>Islamic Azad University, Roudehen branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Pegah Farrokhzad, Mohammad Ebrahim Sarichlou, Hossein Ebrahimi Moghadam, Mahdeh Sadeghpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roudehen - University complex - Islamic Azad University, Roudehen branch</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۷۳۱۸۸۹۸۱</zip>
        <telephone>+98 21 7650 5894</telephone>
        <email>sadeghpoormahdieh@yahoo.com</email>
        <affiliation>Islamic university - Roudehen Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People with breast cancer who have been admitted to the hospital for at least one month after undergoing chemotherapy and radiation therapy or surgery and related side measures.
Patients should be in the age range of 25 to 65 years and have physical ability to attend therapy intervention sessions.
Not receiving cognitive therapy before group therapy sessions or during group therapy sessions.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Existence of psychological disorders or history of the mental illness and hospitalization.
Abuse of narcotics and psychiatric drugs.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of upper-outer quadrant of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Treatment based on acceptance and commitment is held in the form of eight ninety-minute group sessions by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be taken from the participants to check the effectiveness.The content of treatment intervention sessions based on acceptance and commitment includes the following: First session: introduction, stating the basic concepts of treatment, obtaining informed consent, taking a pre-test and examining people's attitudes about unpleasant thoughts and feelings, acceptance and committed action using metaphors and homework.The second session: reviewing past sessions and practicing contact with the present, paying attention to awareness, wanting instead of avoiding, practicing conscious breathing, practicing wanting instead of avoiding using metaphors. Third session: reviewing past sessions, paying attention to awareness and the mental functions of breaking through using metaphors, homework.The fourth session: review of the previous session, examination of values and committed action, examination of obstacles to conduct behavior consistent with values using metaphors and homework.The fifth session: reviewing the previous session, paying attention to awareness and self as a context, identifying the internal obstacles of a valuable life using metaphor, homework.Sixth session: Examining past sessions, paying attention to awareness, making mistakes, breaking grammatical rules using metaphors, homework.The seventh session: stability of the results and review of exercises of the previous session.Eighth session: summing up the sessions and encouraging the participants to continue the exercises after finishing the sessions and treatment, announcing the end of the sessions and taking the post-test.</i_keyword>
      <i_keyword>Intervention group 2: cognitive-behavioral therapy in the form of eight ninety-minute group sessions held by the researcher once a week.First, death anxiety scores, resilience and life expectancy are determined with the pre-test, and after the implementation of eight therapeutic intervention sessions, a post-test will be conducted to check the effectiveness of the participants.The content of cognitive-behavioral intervention sessions is as follows : First session: Introducing and explaining the basic concepts of treatment and recipes and taking the pre-test and explaining the physiological, cognitive, behavioral processes, homework.The second session: review of the previous session, getting to know your own thoughts, cognitive distortions, identifying them in your thinking, recognizing resistance to treatment and designing strategies to deal with it and homework.The third session: reviewing the previous session, getting to know the foundations of behavioral consequences, teaching the nature of schemas, the relationship between schemas and spontaneous thoughts, and identifying schemas through the vertical arrow and homework.The fourth session: review of the previous session, work on the vertical arrow and solve the problems that the research participants have in using the vertical arrow in order to identify their negative schema and homework.The fifth session: review of the previous session, getting the participants a clearer picture of how the negative beliefs are connected and compatible with each other, organizing the list of negative beliefs and homework.Sixth session: review of the previous session, acceptance of the fact that beliefs can be changed and it is possible that people can revise their beliefs and homework.Seventh session: review of the previous session, understanding that beliefs are different in terms of usefulness and they can be evaluated based on criteria and homework.Eighth session: reviewing the previous session, learning the application of logical analysis about their beliefs, participants' achievement of the concept of opposing belief and announcing the end of the sessions and taking the post-test.</i_keyword>
      <i_keyword>Control group 3: general explanation of research objectives and obtaining informed consent and then conducting a pre-test, while the control group does not receive any intervention, and after two months, a post-test is also taken from this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Death anxiety. Timepoint: Before and after the implementation of therapeutic interventions and after a period of three months after the therapeutic interventions. Method of measurement: Using Templer's Death Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: قبل و بعد از اجرای مداخلات درمانی و بعد از گذشت یک دوره سه ماهه بعد از مداخلات درمانی. Method of measurement: پرسشنامه مقیاس تاب آوری کونور و دیودسون.</prim_outcome>
      <prim_outcome>Life expectancy. Timepoint: Before and after the implementation of therapeutic interventions and after a period of three months after the therapeutic interventions. Method of measurement: Schneider life expectancy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before the intervention and 8 sessions after the intervention. Method of measurement: Quality of life questionnaire.</sec_outcome>
      <sec_outcome>Depression. Timepoint: Before the intervention and 8 sessions after the intervention. Method of measurement: Beck depression questionnaire.</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Before the intervention and 8 sessions after the intervention. Method of measurement: Beck's anxiety 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>Islamic Azad University, Roudehen branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-14</approval_date>
        <contact_name>Committees of Islamic Azad University-Roudehen Branch</contact_name>
        <contact_address>Roudehen - University complex of Islamic Azad University Roudehen Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
