<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04405531</url>
  </required_header>
  <id_info>
    <org_study_id>KCTOT</org_study_id>
    <nct_id>NCT04405531</nct_id>
  </id_info>
  <brief_title>Effects of TOT on Performance, Independence and Fatigue in Children With Cancer</brief_title>
  <official_title>Effectiveness of Task-Oriented Training on Occupational Performance, Independence, and Fatigue in Children With Childhood Cancer: A Randomized-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore the effects of Task-Oriented Training (TOT) on occupational&#xD;
      performance, activities of daily living and fatigue of children in pediatric oncology clinic.&#xD;
&#xD;
      Hypothesis: There is no effect of TOT on occupational performance and satisfaction in&#xD;
      children with childhood cancer. There is no effect of TOT on functional independence in daily&#xD;
      living activities in children with childhood cancer. There is no effect of TOT on fatigue&#xD;
      levels in children with childhood cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 13, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>6 months</time_frame>
    <description>COPM is a standard measurement used for measuring the occupational performance and satisfaction in children by identifying their problems in performing activities of daily living. Each of the identified activities was asked to be scored between 1 and 10 on the Likert Scale (1: not important; 10: very important). Performance and satisfaction scores were specified by dividing the total scores of performance and satisfaction to the number of activities that the children regard as substantial. A change of two points or more in the score on COPM is considered clinically significant. In the Turkish version of validity and reliability, the internal consistency coefficient of COPM was found to be between 0.9 and 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Independence Measure for Children (WeeFIM)</measure>
    <time_frame>6 months</time_frame>
    <description>WeeFIM, which is an 18-item and seven-level ordinal scale, measures a child's incoherent performance in basic daily functional skills. It can be used for children with developmental disabilities from 6 months to 21 years. Sub-scales include self-care, sphincter control, movement, transfers, social cognition and communication. The self-care subscale has six items: eating, grooming, bathing, dressing of upper and lower extremities, and the perineal hygiene and adjustment of necessary clothes for the toilet. A scoring scale between 1 (total assistance) to 7 (total independence) was used at this steep. The maximum total score is 126 and the lowest total score is 18, while the maximum scores for self-care, mobility, and cognition are 56, 35, and 35, respectively .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analog scale (VAS)</measure>
    <time_frame>6 months</time_frame>
    <description>VAS is a reliable and easily applicable assessment tool that is accepted worldwide in the literature. VAS is used to transform some immeasurable values into quantitative data. It is a scale in which a person marks his / her current emotion level on a vertical line with a 10-cm scale. Every emotion is evaluated in a range from non-existent (i.e. never experiencing that particular sensation or feeling) to highly intensive (i.e. constantly experiencing that particular sensation or feeling). The following expressions were used on the scale: 'Show me your fatigue level on the line, here is no fatigue (score = 0), and there is the wickedest probable fatigue (score = 10)'. This process was repeated for five times as before activity, during-activity, after activity, and morning and evening time intervals. It took less than 1 minute for each application to get completed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">213</enrollment>
  <condition>Childhood Cancer</condition>
  <condition>Performance</condition>
  <condition>Functional Independence</condition>
  <condition>Fatigue</condition>
  <arm_group>
    <arm_group_label>task-oriented training(TOT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first phase of the TOT, functional activity analysis, was performed for the activities, for which performance problem was determined by Canadian Occupational Performance Measure (COPM) and Functional Independence Measure for Children (WeeFIM). In the second phase, the occupational performance, fatigue and functional independence levels that prevent the realization of the activity were determined by functional activity analysis. These designated occupational performance, fatigue and functional independence levels constitute the task of this study, as we aim to improve children's functionality. In the third phase, various functional activities including these tasks were executed. The TOT was practiced by following the above mentioned steps for each performance area. All the activities were designed for the inpatient settings of children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional occupational therapy (COT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment efficacy determined by the therapist was provided by considering the functional level in order to achieve the desired goal by the participant. The COT included functional activities based on the client-centered principles of the neuro-developmental approach. All the sessions started with relaxation training combined with breathing exercises. At the end of approximately 10 minutes of application time, individualized functional activities were implemented.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>task-oriented training (TOT)</intervention_name>
    <description>The study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting.</description>
    <arm_group_label>task-oriented training(TOT)</arm_group_label>
    <other_name>TOT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional occupational therapy (COT)</intervention_name>
    <description>The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.</description>
    <arm_group_label>conventional occupational therapy (COT)</arm_group_label>
    <arm_group_label>task-oriented training(TOT)</arm_group_label>
    <other_name>COT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being between 6 and 14 years of age;&#xD;
&#xD;
          -  receiving inpatient chemotherapy sessions;&#xD;
&#xD;
          -  having taken scores higher than 28, 30 and 35 in the mini-mental state exam devised&#xD;
             for children of ages 6-8, 9-11 and 12-14, respectively.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  their disease had recurred, or they were in palliative care;&#xD;
&#xD;
          -  they or their parents were not fluent speakers of the Turkish language;&#xD;
&#xD;
          -  they were unwilling to take part in the programs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeynep Kolit, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sedef Şahin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ceren Davutoğlu, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Meral Huri, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <state>Sıhhiye</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 16, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>ZEYNEP KOLİT</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>childhood cancer</keyword>
  <keyword>fatigue</keyword>
  <keyword>functional independence</keyword>
  <keyword>occupational performance</keyword>
  <keyword>task-oriented training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405531
org study id: KCTOT
nct id: NCT04405531
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to explore the effects of Task-Oriented Training (TOT) on occupational
      performance, activities of daily living and fatigue of children in pediatric oncology clinic.

      Hypothesis: There is no effect of TOT on occupational performance and satisfaction in
      children with childhood cancer. There is no effect of TOT on functional independence in daily
      living activities in children with childhood cancer. There is no effect of TOT on fatigue
      levels in children with childhood cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Canadian Occupational Performance Measure (COPM)
time frame: 6 months
description: COPM is a standard measurement used for measuring the occupational performance and satisfaction in children by identifying their problems in performing activities of daily living. Each of the identified activities was asked to be scored between 1 and 10 on the Likert Scale (1: not important; 10: very important). Performance and satisfaction scores were specified by dividing the total scores of performance and satisfaction to the number of activities that the children regard as substantial. A change of two points or more in the score on COPM is considered clinically significant. In the Turkish version of validity and reliability, the internal consistency coefficient of COPM was found to be between 0.9 and 1.
measure: Functional Independence Measure for Children (WeeFIM)
time frame: 6 months
description: WeeFIM, which is an 18-item and seven-level ordinal scale, measures a child's incoherent performance in basic daily functional skills. It can be used for children with developmental disabilities from 6 months to 21 years. Sub-scales include self-care, sphincter control, movement, transfers, social cognition and communication. The self-care subscale has six items: eating, grooming, bathing, dressing of upper and lower extremities, and the perineal hygiene and adjustment of necessary clothes for the toilet. A scoring scale between 1 (total assistance) to 7 (total independence) was used at this steep. The maximum total score is 126 and the lowest total score is 18, while the maximum scores for self-care, mobility, and cognition are 56, 35, and 35, respectively .
measure: Visual analog scale (VAS)
time frame: 6 months
description: VAS is a reliable and easily applicable assessment tool that is accepted worldwide in the literature. VAS is used to transform some immeasurable values into quantitative data. It is a scale in which a person marks his / her current emotion level on a vertical line with a 10-cm scale. Every emotion is evaluated in a range from non-existent (i.e. never experiencing that particular sensation or feeling) to highly intensive (i.e. constantly experiencing that particular sensation or feeling). The following expressions were used on the scale: 'Show me your fatigue level on the line, here is no fatigue (score = 0), and there is the wickedest probable fatigue (score = 10)'. This process was repeated for five times as before activity, during-activity, after activity, and morning and evening time intervals. It took less than 1 minute for each application to get completed.
arm group label: task-oriented training(TOT)
arm group type: Experimental
description: The first phase of the TOT, functional activity analysis, was performed for the activities, for which performance problem was determined by Canadian Occupational Performance Measure (COPM) and Functional Independence Measure for Children (WeeFIM). In the second phase, the occupational performance, fatigue and functional independence levels that prevent the realization of the activity were determined by functional activity analysis. These designated occupational performance, fatigue and functional independence levels constitute the task of this study, as we aim to improve children's functionality. In the third phase, various functional activities including these tasks were executed. The TOT was practiced by following the above mentioned steps for each performance area. All the activities were designed for the inpatient settings of children.
arm group label: conventional occupational therapy (COT)
arm group type: Experimental
description: The treatment efficacy determined by the therapist was provided by considering the functional level in order to achieve the desired goal by the participant. The COT included functional activities based on the client-centered principles of the neuro-developmental approach. All the sessions started with relaxation training combined with breathing exercises. At the end of approximately 10 minutes of application time, individualized functional activities were implemented.
intervention type: Other
intervention name: task-oriented training (TOT)
description: The study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting.
arm group label: task-oriented training(TOT)
other name: TOT
intervention type: Other
intervention name: conventional occupational therapy (COT)
description: The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.
arm group label: conventional occupational therapy (COT)
arm group label: task-oriented training(TOT)
other name: COT
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: No
last name: Zeynep Kolit, MSc
role: Principal Investigator
affiliation: Hacettepe University
last name: Sedef Şahin, PhD
role: Study Director
affiliation: Hacettepe University
last name: Ceren Davutoğlu, MSc
role: Principal Investigator
affiliation: Hacettepe University
last name: Meral Huri, PhD
role: Study Chair
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: ZEYNEP KOLİT
investigator title: Principal Investigator
mesh term: Fatigue
sharing ipd: No