- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01682824
Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Cohorts and Interventions
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.
|
Complete dietary intake assessment
Other Names:
Complete TFEQ-R18v2 questionnaire
Complete EQ-EMA questionnaire
|
Group II (questionnaire, nutritional assessment)
Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.
|
Complete dietary intake assessment
Other Names:
Complete TFEQ-R18v2 questionnaire
Complete EQ-EMA questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 6 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-0628 (Other Identifier: M D Anderson Cancer Center)
- NCI-2018-02536 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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