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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01682824
Other study ID # 2012-0628
Secondary ID NCI-2018-0253620
Status Completed
Phase
First received
Last updated
Start date May 17, 2013
Est. completion date January 24, 2022

Study information

Verified date February 2022
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date January 24, 2022
Est. primary completion date January 24, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 39 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nutritional Assessment
Complete dietary intake assessment
Questionnaire Administration
Complete TFEQ-R18v2 questionnaire
Questionnaire Administration
Complete EQ-EMA questionnaire

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2) 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. Up to 6 years
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