Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
Primary Purpose
Cancer Survivor
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Nutritional Assessment
Questionnaire Administration
Questionnaire Administration
Sponsored by
About this trial
This is an observational trial for Cancer Survivor
Eligibility 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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Group I (questionnaire, nutritional assessment)
Group II (questionnaire, nutritional assessment)
Arm Description
Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.
Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01682824
First Posted
August 20, 2012
Last Updated
February 1, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01682824
Brief Title
Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
Official Title
MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors
Study Type
Observational
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2013 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
January 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor
7. Study Design
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (questionnaire, nutritional assessment)
Arm Description
Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.
Arm Title
Group II (questionnaire, nutritional assessment)
Arm Description
Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.
Intervention Type
Other
Intervention Name(s)
Nutritional Assessment
Other Intervention Name(s)
Dietary Assessment, dietary counseling, nutritional counseling
Intervention Description
Complete dietary intake assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete TFEQ-R18v2 questionnaire
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete EQ-EMA questionnaire
Primary Outcome Measure Information:
Title
Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2)
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.
Time Frame
Up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
MDACC participants
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Basen-Engquist
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
We'll reach out to this number within 24 hrs