ClinicalTrials.gov
ClinicalTrials.gov Menu

Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01682824
Recruitment Status : Active, not recruiting
First Posted : September 11, 2012
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Cancer Survivor Other: Nutritional Assessment Other: Questionnaire Administration

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 250 participants
Official Title: MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors
Actual Study Start Date : May 17, 2013
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Group I (questionnaire, nutritional assessment)
Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.
Other: Nutritional Assessment
Complete dietary intake assessment
Other Names:
  • Dietary Assessment
  • dietary counseling
  • nutritional counseling

Other: Questionnaire Administration
Complete TFEQ-R18v2 questionnaire

Other: Questionnaire Administration
Complete EQ-EMA questionnaire

Group II (questionnaire, nutritional assessment)
Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.
Other: Nutritional Assessment
Complete dietary intake assessment
Other Names:
  • Dietary Assessment
  • dietary counseling
  • nutritional counseling

Other: Questionnaire Administration
Complete TFEQ-R18v2 questionnaire

Other: Questionnaire Administration
Complete EQ-EMA questionnaire




Primary Outcome Measures :
  1. Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2) [ Time Frame: Up to 6 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MDACC participants
Criteria

Inclusion Criteria:

  • Adolescent or young adult (AYA) who has survived a primary CNS tumor
  • Has been off therapy without relapse for at least 6 months
  • Able to speak, write, and read in English
  • Has access to the internet
  • Has telephone access
  • Currently lives in the United States

Exclusion Criteria:

  • Is in foster care
  • Is experiencing severe cognitive impairments that do not allow them to engage in basic conversations (excluding individuals who may experience severe cognitive impairments because participants will need to provide assent [if < 18 years old] or consent [if >= 18 years old] and will need to have the ability to independently complete the TFEQ-R18v2, Multifactor screener, and EQ-EMA. Through the phone screening conducted by the M D Anderson Cancer Center [MDACC] graduate research assistant [GRA], a person is determined to not be severely cognitive impaired if the participant is able to respond to basic questions such as their age, whether or not they have internet access, and telephone.)
  • Is incarcerated at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682824


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen Basen-Engquist M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01682824     History of Changes
Other Study ID Numbers: 2012-0628
NCI-2018-02536 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012-0628 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No