<?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>IRCT20200516047463N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Rehabilitation on Memory in Children Survived from Cancer</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Cognitive Rehabilitation Training and Memory and Attention Adaptation Training on Working memory, Attention, Processing Speed and Executive Function in Children Survived from Cancer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48183</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To assign subjects, a random matching method is used. Subjects are personally matched and paired by age and gender. Each of the two was assigned with a number and then with simple random method, one of the numbers assigned to experimental group and the other number assigned to control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute lymphoblastic leukemia with a history of chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: first group, Cognitive Rehabilitation Training, This training method includes 12 50-minute sessions that are held once a week. The first 20 minutes of the session are devoted to practical cognitive rehabilitation exercises. Exercises such as: time-reducing techniques, content memorization techniques, increasing the field of view using the card, measuring reading speed, visual memory exercises using the card, finding differences and similarities in images with time recording, Memory games such as recalling spoken words or naming objects seen in the picture, auditory memory exercises, etc. Then in the last 30 minutes of the session, the subject will use memory and concentration software to perform visual and auditory memory exercises. In this research, the Persian version of Cogmed software will be used. During each session, the subject should first perform forward visual and auditory exercises and then reverse visual and auditory exercises. Intervention 2: Intervention group: second group, Memory and Attention Adaptation, This training method includes 4 one-hour face-to-face sessions that are held once every 2 weeks, and 3 phone calls at intervals of each face-to-face session, to follow up on homework and troubleshooting. In the fourth session, relapse prevention methods will be taught to the person and after a few months, a face-to-face session can be requested to review the treatment process. Specific techniques used in this method are drawn from the cognitive-behavior therapy(CBT). Memory and Attention Adaptation Training is organized into four components: (1) education (on chemotherapy related cognitive problems and other influences on attention and memory such as stress); (2) self-awareness training (self-monitoring to identify “at risk” situations or conditions associated with cognitive failure); (3) compensatory cognitive skills training; and (4) applied relaxation training for arousal reduction. Intervention 3: Control group: no intervention.</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:
Questionnaires completed in the pre-test, post-test and follow-up stages can be provided

When:
access period after printing the results

To whom:
Researchers

Conditions:
In order to verify the results

Where to obtain:
nfsh.reyhani@gmail.com

How to obtain:
The proposal of the research project should be sent along with the request for access to the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nafiseh Damreihani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, Mahan building, 64/1 lane, Pasdaran boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184967773</zip>
        <telephone>+98 71 3833 4383</telephone>
        <email>nfsh.reyhani@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nafiseh Damreihani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, Mahan building, 64/1 lane, Pasdaran boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7184967773</zip>
        <telephone>+98 71 3833 4383</telephone>
        <email>nfsh.reyhani@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 6 to 16 years old
Having a diagnosis of acute lymphoblastic leukemia
With the history of chemotherapy
Weakness with at least one standard deviation in research variables
Satisfaction with participating in research</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Suffering from other kinds of cancer
Using of combined medical treatment methods (chemotherapy along with radiation therapy)
Other chronic physical illnesses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute lymphoblastic leukemia [ALL]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: first group, Cognitive Rehabilitation Training, This training method includes 12 50-minute sessions that are held once a week. The first 20 minutes of the session are devoted to practical cognitive rehabilitation exercises. Exercises such as: time-reducing techniques, content memorization techniques, increasing the field of view using the card, measuring reading speed, visual memory exercises using the card, finding differences and similarities in images with time recording, Memory games such as recalling spoken words or naming objects seen in the picture, auditory memory exercises, etc. Then in the last 30 minutes of the session, the subject will use memory and concentration software to perform visual and auditory memory exercises. In this research, the Persian version of Cogmed software will be used. During each session, the subject should first perform forward visual and auditory exercises and then reverse visual and auditory exercises.</i_keyword>
      <i_keyword>Intervention group: second group, Memory and Attention Adaptation, This training method includes 4 one-hour face-to-face sessions that are held once every 2 weeks, and 3 phone calls at intervals of each face-to-face session, to follow up on homework and troubleshooting. In the fourth session, relapse prevention methods will be taught to the person and after a few months, a face-to-face session can be requested to review the treatment process. Specific techniques used in this method are drawn from the cognitive-behavior therapy(CBT). Memory and Attention Adaptation Training is organized into four components: (1) education (on chemotherapy related cognitive problems and other influences on attention and memory such as stress); (2) self-awareness training (self-monitoring to identify “at risk” situations or conditions associated with cognitive failure); (3) compensatory cognitive skills training; and (4) applied relaxation training for arousal reduction.</i_keyword>
      <i_keyword>Control group: no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of working memory in Wechsler Intelligence Scale for Children- Fourth Edition. Timepoint: Before the intervention, after the intervention, 2 months after the end of the intervention. Method of measurement: Wechsler Intelligence Scale for Children- Fourth Edition.</prim_outcome>
      <prim_outcome>Score of processing speed in Wechsler Intelligence Scale for Children- Fourth Edition. Timepoint: Before the intervention, after the intervention, 2 months after the end of the intervention. Method of measurement: Wechsler Intelligence Scale for Children- Fourth Edition.</prim_outcome>
      <prim_outcome>Score of attention in Stroop test. Timepoint: Before the intervention, after the intervention, 2 months after the end of the intervention. Method of measurement: Stroop test.</prim_outcome>
      <prim_outcome>Score of executive functions in Behavior Rating Inventory of Executive Function. Timepoint: Before the intervention, after the intervention, 2 months after the end of the intervention. Method of measurement: Behavior Rating Inventory of Executive Function.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-11</approval_date>
        <contact_name>Ethics committe of Islamic Azad University- Shiraz Branch</contact_name>
        <contact_address>No.7, Karen building, 64/1 lane, Pasdaran boulevard Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
