<?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>IRCT20190921044831N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-17</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) and Schema Therapy on Referral thinking, Psychological flexibility, Quality of life and Nausea and Vomiting due to Chemotherapy in Women with Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74976</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Fifty-four women will be selected through available sampling among the women who are eligible to enter the study, and after a clear explanation of the objectives of the study and completion of an informed and voluntary written consent form, they will be invited to participate in the study. Then, by simple random sampling method, volunteers will be divided into three groups, two intervention groups "one and two" and one control group, and the study will enter its therapeutic intervention phase, Blinding description: The participants do not know about the therapeutic intervention in other groups, and their choice to be in each of the three groups is completely random. The time of meetings is planned so that people in different groups do not meet each other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and Commitment Therapy: ACT. Intervention 2: Intervention group: Schema therapy.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Participant data contains their demographic information without mentioning personal information. The study protocol includes the method of sampling, assigning interventions to groups, and how to implement them. The analysis of details is based on the quantitative statistical analysis of people's scores according to the questionnaires used. The informed consent form is designed based on the rules of conducting clinical trial studies, and its report is published in the form of an original scientific article.

When:
Access starts one year after the article is published

To whom:
Researchers working in reputable scientific and research institutions

Conditions:
In case of receiving reliable information about conducting a related study and under the condition of referencing and maintaining trustworthiness in the information, in order to help reach a consensus of different results related to the subject.

Where to obtain:
Correspondent author of the manuscript

How to obtain:
The person informs the author of the article about his request via email, and after checking the information about the applicant and consulting with other authors, the information is provided with special conditions.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahrzad Sepehr Yeganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir al-Momenin University Complex, the intersection of Mozen and Esteghlal Blvd., At the end of Rajaee Shahr.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3425 9571</telephone>
        <email>yeganehsepehr@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrzad Sepehr Yeganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amir al-Momenin University Complex, the intersection of Mozen and Esteghlal Blvd., At the end of Rajaee Shahr.</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149968111</zip>
        <telephone>+98 26 3425 9571</telephone>
        <email>yeganesepehr@yahoo.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The person's satisfaction and willingness to participate in the study.
Having breast cancer
Carrying out the chemotherapy process
Having at least 8th grade education
Not suffering from severe mental disorders</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The time interval from the definitive diagnosis of the disease is less than two months
History of other malignancies
Having two consecutive absences from meetings
Unwillingness to cooperate
Use of complementary therapies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C43.5, C44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breastIncl.:connective tissue of breastExcl.:skin of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and Commitment Therapy: ACT</i_keyword>
      <i_keyword>Intervention group: Schema therapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Referral thinking: Negative referential thinking is a type of thinking about negative experiences that has three characteristics: repetitiveness, spontaneity, and difficulty in interrupting thoughts. Timepoint: 10 sessions. Method of measurement: Ehring's Referential Thinking Questionnaire.</prim_outcome>
      <prim_outcome>Psychological flexibility: The ability to abstract and change cognitive strategies is based on changes in environmental feedback, which requires planning, organized search, and the ability to use environmental feedback to change cognitive patterns. Timepoint: 10 sessions. Method of measurement: Psychological Flexibility Scale: This questionnaire is a 24-question short self-report tool that measures the type of flexibility that is necessary in a person's success to challenge and replace inefficient thoughts with more efficient ones.</prim_outcome>
      <prim_outcome>Quality of life is the perception of each person about his health condition and the level of satisfaction with these conditions. The World Health Organization defines quality of life as a person's understanding of his place in life in the context of the culture and values system in which he lives, which is related to his goals, expectations, standards and concerns. Timepoint: 10 sessions. Method of measurement: WHOQO-BREF ًquestionnaire.</prim_outcome>
      <prim_outcome>Chemotherapy-induced nausea and vomiting. Timepoint: 10 sessions. Method of measurement: Score from questionnaire and nausea and vomiting index form (INV-2) (Rhodes et al., 1986).</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>Karaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-28</approval_date>
        <contact_name>Medical ethics committee of Islamic Azad University of Karaj</contact_name>
        <contact_address>Karaj, the end of Rajaee Shahr, the intersection of Mozen and Esteghlal Blvd., Amirul Mominin University Complex (AS) karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
