<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/NCT01682824</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0628</org_study_id>
    <secondary_id>NCI-2018-02536</secondary_id>
    <secondary_id>2012-0628</secondary_id>
    <nct_id>NCT01682824</nct_id>
  </id_info>
  <brief_title>Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors</brief_title>
  <official_title>MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</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 trial studies how the Three-Factor Eating Questionnaire works in measuring eating&#xD;
      behavior in adolescent and young adult survivors of central nervous system (CNS) tumors. The&#xD;
      Three-Factor Eating Questionnaire is comprised of three factors, including cognitive&#xD;
      restraint, uncontrolled eating, and emotion eating. The Eating Questionnaire - Ecological&#xD;
      Momentary Assessment method measures a patient's recent experiences and behavior, such as&#xD;
      eating behavior, as they continue their daily living. Giving the Three-Factor Eating&#xD;
      Questionnaire and the Eating Questionnaire - Ecological Momentary Assessment may help&#xD;
      researchers measure eating behaviors more effectively in adolescent and young adult survivors&#xD;
      of CNS tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES I. Evaluate whether the factor structure of the adapted Eating&#xD;
      Questionnaire-Ecological Momentary Assessment (EQ-EMA), which has been modified for real time&#xD;
      assessment, will be similar to the factor structures for cognitive restraint (CR) and&#xD;
      uncontrollable eating (UE) factors assessed by the Three Factor Eating Questionnaire-R18v2&#xD;
      (TFEQ-R18v2) in a sample of adolescent and young adult (AYA) survivors of childhood central&#xD;
      nervous system (CNS) tumors in the United States (US).&#xD;
&#xD;
      SECONDARY OBJECTIVES I. To validate the original TFEQ-R18v2 in a sample of AYA survivors of&#xD;
      childhood CNS tumors in the US.&#xD;
&#xD;
      II. To determine the association of the original TFEQ-R18v2 with self-reported body mass&#xD;
      index (BMI).&#xD;
&#xD;
      III. To determine the association of the original TFEQ-R18v2 with fruits and vegetables,&#xD;
      fiber, and fat intake.&#xD;
&#xD;
      IV. To determine the association of EQ-EMA with self-reported BMI. V. To determine the&#xD;
      association of EQ-EMA with fruits and vegetables, fiber, and fat intake.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I: Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the&#xD;
      EQ-EMA questionnaire online.&#xD;
&#xD;
      GROUP II: Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the&#xD;
      TFEQ-R18v2 questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2013</start_date>
  <completion_date type="Actual">January 24, 2022</completion_date>
  <primary_completion_date type="Actual">January 24, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2)</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Will use a structural equation modeling (SEM) methodology to examine the extent to which individual items comprising both the original TFEQ-R18v2 and the adapted EQ-EMA loaded on their respective factors (cognitive restraint [CR] and uncontrollable eating [UE]) and will examine the correlations between them.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Cancer Survivor</condition>
  <arm_group>
    <arm_group_label>Group I (questionnaire, nutritional assessment)</arm_group_label>
    <description>Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (questionnaire, nutritional assessment)</arm_group_label>
    <description>Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutritional Assessment</intervention_name>
    <description>Complete dietary intake assessment</description>
    <arm_group_label>Group I (questionnaire, nutritional assessment)</arm_group_label>
    <arm_group_label>Group II (questionnaire, nutritional assessment)</arm_group_label>
    <other_name>Dietary Assessment</other_name>
    <other_name>dietary counseling</other_name>
    <other_name>nutritional counseling</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete TFEQ-R18v2 questionnaire</description>
    <arm_group_label>Group I (questionnaire, nutritional assessment)</arm_group_label>
    <arm_group_label>Group II (questionnaire, nutritional assessment)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete EQ-EMA questionnaire</description>
    <arm_group_label>Group I (questionnaire, nutritional assessment)</arm_group_label>
    <arm_group_label>Group II (questionnaire, nutritional assessment)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        MDACC participants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent or young adult (AYA) who has survived a primary CNS tumor&#xD;
&#xD;
          -  Has been off therapy without relapse for at least 6 months&#xD;
&#xD;
          -  Able to speak, write, and read in English&#xD;
&#xD;
          -  Has access to the internet&#xD;
&#xD;
          -  Has telephone access&#xD;
&#xD;
          -  Currently lives in the United States&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is in foster care&#xD;
&#xD;
          -  Is experiencing severe cognitive impairments that do not allow them to engage in basic&#xD;
             conversations (excluding individuals who may experience severe cognitive impairments&#xD;
             because participants will need to provide assent [if &lt; 18 years old] or consent [if &gt;=&#xD;
             18 years old] and will need to have the ability to independently complete the&#xD;
             TFEQ-R18v2, Multifactor screener, and EQ-EMA. Through the phone screening conducted by&#xD;
             the M D Anderson Cancer Center [MDACC] graduate research assistant [GRA], a person is&#xD;
             determined to not be severely cognitive impaired if the participant is able to respond&#xD;
             to basic questions such as their age, whether or not they have internet access, and&#xD;
             telephone.)&#xD;
&#xD;
          -  Is incarcerated at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Basen-Engquist</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Central Nervous System Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01682824
org study id: 2012-0628
secondary id: NCI-2018-02536
secondary id: 2012-0628
nct id: NCT01682824
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies how the Three-Factor Eating Questionnaire works in measuring eating
      behavior in adolescent and young adult survivors of central nervous system (CNS) tumors. The
      Three-Factor Eating Questionnaire is comprised of three factors, including cognitive
      restraint, uncontrolled eating, and emotion eating. The Eating Questionnaire - Ecological
      Momentary Assessment method measures a patient's recent experiences and behavior, such as
      eating behavior, as they continue their daily living. Giving the Three-Factor Eating
      Questionnaire and the Eating Questionnaire - Ecological Momentary Assessment may help
      researchers measure eating behaviors more effectively in adolescent and young adult survivors
      of CNS tumors.
PRIMARY OBJECTIVES I. Evaluate whether the factor structure of the adapted Eating
      Questionnaire-Ecological Momentary Assessment (EQ-EMA), which has been modified for real time
      assessment, will be similar to the factor structures for cognitive restraint (CR) and
      uncontrollable eating (UE) factors assessed by the Three Factor Eating Questionnaire-R18v2
      (TFEQ-R18v2) in a sample of adolescent and young adult (AYA) survivors of childhood central
      nervous system (CNS) tumors in the United States (US).

      SECONDARY OBJECTIVES I. To validate the original TFEQ-R18v2 in a sample of AYA survivors of
      childhood CNS tumors in the US.

      II. To determine the association of the original TFEQ-R18v2 with self-reported body mass
      index (BMI).

      III. To determine the association of the original TFEQ-R18v2 with fruits and vegetables,
      fiber, and fat intake.

      IV. To determine the association of EQ-EMA with self-reported BMI. V. To determine the
      association of EQ-EMA with fruits and vegetables, fiber, and fat intake.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the
      EQ-EMA questionnaire online.

      GROUP II: Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the
      TFEQ-R18v2 questionnaire.
measure: Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2)
time frame: Up to 6 years
description: Will use a structural equation modeling (SEM) methodology to examine the extent to which individual items comprising both the original TFEQ-R18v2 and the adapted EQ-EMA loaded on their respective factors (cognitive restraint [CR] and uncontrollable eating [UE]) and will examine the correlations between them.
arm group label: Group I (questionnaire, nutritional assessment)
description: Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.
arm group label: Group II (questionnaire, nutritional assessment)
description: Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.
intervention type: Other
intervention name: Nutritional Assessment
description: Complete dietary intake assessment
arm group label: Group I (questionnaire, nutritional assessment)
arm group label: Group II (questionnaire, nutritional assessment)
other name: Dietary Assessment
other name: dietary counseling
other name: nutritional counseling
intervention type: Other
intervention name: Questionnaire Administration
description: Complete TFEQ-R18v2 questionnaire
arm group label: Group I (questionnaire, nutritional assessment)
arm group label: Group II (questionnaire, nutritional assessment)
intervention type: Other
intervention name: Questionnaire Administration
description: Complete EQ-EMA questionnaire
arm group label: Group I (questionnaire, nutritional assessment)
arm group label: Group II (questionnaire, nutritional assessment)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 39 Years
healthy volunteers: No
last name: Karen Basen-Engquist
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Central Nervous System Neoplasms