<?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>IRCT20210727052000N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Acceptance and Commitment Therapy on adolescents with cancer experience</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of applicability and feasibility and the effectiveness of acceptance and commitment therapy on quality of life and psychological flexibility of adolescent survivors with cancer experience</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be available, but random allocation will be done by the professor of biostatistics without the knowledge of the patients and the therapist using the block method with the size of blocks of 3 and using sealed envelopes, Blinding description: After the initial sampling, patients and therapists are unaware that the patients will be in the control or intervention group. The statistical consultant professor performs block randomization.</study_design>
      <phase>3</phase>
      <hc_freetext>Adolescents survivors of cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the experimental group, survival adolescents from cancer receive 3 sessions that each session lasts 90-minute based on acceptance and commitment therapy that is compatible to their illness's conditions. Acceptance and commitment therapy is a type of contextual and experimental behavioral therapy and based on mindfulness that was developed by Dr. Steven Hayes in 1982, mentioned therapy is one of the third wave of psychological therapies. It consists of six basic processes: acceptance, cognitive defusion, being in the present moment, self as context, values and commitment. In fact, acceptance and commitment therapy means: accepting what is out of your control and committing to something that you can change and improves your living conditions. Intervention 2: Control group: They donot recieve  a psychotherapy. After the 3-months follow-up, they can recieve it if they want.</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 will be presented in the form of tables and graphs in the article. If requested by the judges or the editor, it will be made available to them after de-identification.

When:
The access period starts 6 months after the publication of the article

To whom:
Only researchers

Conditions:
In order to use the results, methodology and tools used by researchers, they can send a request.

Where to obtain:
To the responsible author or Fatima Hassani Ali Malek by email: fatima.hassani75@yahoo.com

How to obtain:
After receiving the email, the responsible author will be talked to, and if the request is correct, the requested information will be provided to the requester as soon as possible.

Comments:
Not worth mentioning.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hassani Alimolk</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, above Valiasr Square, Sheikh Fazullah Nouri Highway</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515777978</zip>
        <telephone>+98 24 3377 0802</telephone>
        <email>fatima.hassani75@yahoo.com</email>
        <affiliation>Valiaasr Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zhaleh Karmimoghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Mahdavi street</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3314 0201</telephone>
        <email>zhkarimi@zums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 13-18 years
Completion of cancer treatment
Not having psychiatric medicine for reducing anxiety or depression
Not having psychotherapy now or last 3 months
No diagnosis of conduct disorders, confrontational disobedience, ADHD, and psychotic and bipolar spectrum disorders</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction of the adolescent or family with the continuation of treatment
Cancer recurrence</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>COO-D48</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>adolescent with cancer</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the experimental group, survival adolescents from cancer receive 3 sessions that each session lasts 90-minute based on acceptance and commitment therapy that is compatible to their illness's conditions. Acceptance and commitment therapy is a type of contextual and experimental behavioral therapy and based on mindfulness that was developed by Dr. Steven Hayes in 1982, mentioned therapy is one of the third wave of psychological therapies. It consists of six basic processes: acceptance, cognitive defusion, being in the present moment, self as context, values and commitment. In fact, acceptance and commitment therapy means: accepting what is out of your control and committing to something that you can change and improves your living conditions.</i_keyword>
      <i_keyword>Control group: They donot recieve  a psychotherapy. After the 3-months follow-up, they can recieve it if they want.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: pre-test, post-test, 3 months follow-up. Method of measurement: The score of a person from the Adolescent Quality of Life Questionnaire (13-18 years old).</prim_outcome>
      <prim_outcome>Experimental avoidance. Timepoint: pre-test, post-test, follow-up. Method of measurement: Person's score from the Acceptance Avoidance subscale of the Acceptance and Action Questionnaire (AAQ-II).</prim_outcome>
      <prim_outcome>Psychological flexibility. Timepoint: pre-test, post-test, follow-up. Method of measurement: Person's score from the Acceptance and Practice Questionnaire (AAQ-II).</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-15</approval_date>
        <contact_name>Cancer Institute of Tehran university of the medical sciences</contact_name>
        <contact_address>Iran cancer institute/ East door of Imam Khomeini Hospital (RA)/ End of Keshavarz Blvd/ Tehran/ Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
