<?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>IRCT20211107052984N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-02</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of internet-based Act in breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of internet-based Acceptance And Commitment Therapy on Acceptance of Illness, Emotional Regulation and Reduction of Symptom Interference with Function in Patients with Breast Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59840</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: -, Randomization description: The sample size consists of 36 women. There are currently three models of random allocation, and since this study is in two groups, the first generation prototyping model is used, each sample is placed in a treatment group and is done through the site https : // www. .randomize.net / which means that the assignment of samples to each of the two groups does not occur in the order of A and B, respectively, in the order in which the software output is placed.
Groups A and B enter the treatment groups section through the blocks on the site, The samples are then entered in the number of people in the treatment blocks, where the software randomly assigns each of the samples to one of the two groups A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Internet-based  Acceptance And Commitment Therapy                          *Session 1: Housekeeping, Group Culture, Conceptualization, Creative Hopelessness  *Session 2: Control as the Problem/Willingness  *Session 3: Willingness/Defusion  *Session 4: Deliteralization /Defusion  *Session 5: Contacting the Present  *Session 6: Self-as-Context  *Session 7: Values Clarification  *Session 8: Committed Action  *Session 9: Pulling it all together  *Session 10:Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye. Intervention 2: Control group(Education/Support): *Session 1: *Session 2: Overview of quality of life issues *Session 3:Discussion of physical quality of life  *Session 4:Discussion of social quality of life and referral to resources *Session 5:Discussion of emotional quality of life and referral to resources *Session 6:Discussion of Cognitive and spiritual quality of life quality of life and referral to resources *Session 7: Discussion of quality of financial life and referral to resources *Session 8 :Tips for evaluating health information in books,magazines, and websites  *Session 9 : Review of prior sessions and referral to websites with cancer-related information *Session 10 :Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye.</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:
The data are potentially shareable after patients are unidentifiable.

When:
After completing the process and publishing the article.

To whom:
It will be accessible to researchers, students, medical staff and patients.

Conditions:
If it is for the purpose of  scientific advancement and therapeutic progress of patients as well as the expansion of the present research, sending the request is unrestricted.

Where to obtain:
Phone number:
00989133826394
email:
saramirzaeiii997@gmail.com

How to obtain:
After sending the necessary and relevant requests and reviews by the professors and the Masca Center, the applicant will receive the documents.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Psychologyّ،Isfahan University of Medical Sciences</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 9313</telephone>
        <email>saramirzaeiii997@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Psychologyّ،Isfahan University of Medical Sciences</address>
        <city>Student</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3668 9313</telephone>
        <email>saramirzaeiii997@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of the first and second stages of breast cancer
Age group under 55 years
At least 2 months and at most 6 months have passed from their active treatment
Lack of major psychiatric disorders such as schizophrenia and bipolar
Lack of other severe and chronic physical illnesses
Not receiving hospital care at the time of registration
Lack of severe inability to perform activities
Having motivation and desire to participate in psychotherapy sessions
Internet access</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue the treatment process
Absence for more than 2 consecutive sessions and 3 sessions in general
The occurrence of major and severe physical problems
Hospitalization
Failure to complete the questionnaires</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Internet-based  Acceptance And Commitment Therapy                          *Session 1: Housekeeping, Group Culture, Conceptualization, Creative Hopelessness  *Session 2: Control as the Problem/Willingness  *Session 3: Willingness/Defusion  *Session 4: Deliteralization /Defusion  *Session 5: Contacting the Present  *Session 6: Self-as-Context  *Session 7: Values Clarification  *Session 8: Committed Action  *Session 9: Pulling it all together  *Session 10:Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye.</i_keyword>
      <i_keyword>Control group(Education/Support): *Session 1: *Session 2: Overview of quality of life issues *Session 3:Discussion of physical quality of life  *Session 4:Discussion of social quality of life and referral to resources *Session 5:Discussion of emotional quality of life and referral to resources *Session 6:Discussion of Cognitive and spiritual quality of life quality of life and referral to resources *Session 7: Discussion of quality of financial life and referral to resources *Session 8 :Tips for evaluating health information in books,magazines, and websites  *Session 9 : Review of prior sessions and referral to websites with cancer-related information *Session 10 :Conclusion and Ask about useful aspects of therapy ,Ask about areas that client will struggle with going forward and Say goodbye.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional Regulation. Timepoint: Before the intervention (Pre-test),After the intervention (Post-test),12 weeks after the intervention. Method of measurement: Difficulties in Emotion Regulation Scale.</prim_outcome>
      <prim_outcome>Acceptance of Illness. Timepoint: Before the intervention (Pre-test) ,After the intervention (Post-test),12 weeks after the intervention. Method of measurement: acceptance of illness scale questionnaire.</prim_outcome>
      <prim_outcome>Symptom Interference with Function. Timepoint: Before the intervention (Pre-test),After the intervention (Post-test),12 weeks after the intervention. Method of measurement: The MD Anderson Symptom Inventory.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-06</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine-Isfahan University of Medical Sciences</contact_name>
        <contact_address>Department of Health Psychologyّ،Isfahan University of Medical Sciences Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
