MyChoice: An Application of the TFEQ-R18v2

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Baylor College of Medicine
Texas Children's Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01682824
First received: August 20, 2012
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

The goal of this research study is to learn more about eating practices of survivors of childhood Central Nervous System (CNS) tumors (including brain and spinal cord tumors).

Recent research shows that childhood cancer survivors are experiencing many health issues months or even years after active cancer treatment (for example, irregular blood sugar levels, overweight/obesity, and heart disease). To address this growing concern, researchers at MD Anderson Children's Cancer Hospital and Texas Children's Cancer Center have joined forces to learn more about how to design a program that would promote healthy lifestyles among survivors of childhood cancer.


Condition Intervention
Central Nervous System Neoplasms
Behavioral: Three-Factor Eating Questionnaire (TFEQ)-R18v2
Behavioral: Multifactor Screener
Behavioral: Eating Questionnaire-EMA (EQ-EMA)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of Central Nervous System (CNS) Tumors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Factor Structure Comparisons of Eating Questionnaires [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Structural equation modeling (SEM) methodology (i.e. confirmatory factor analysis) used to examine extent to which individual items comprising both the original Three Factor Eating Questionnaire-R18v2 (TFEQ-R18v2) and the adapted Eating Questionnaire-Ecological Momentary Assessment (EQ-EMA) loaded on their respective factors cognitive restraint and uncontrollable eating (CR and UE) and will examine the correlations between them. Analyses conducted using Mplus (version 6.12).


Estimated Enrollment: 250
Study Start Date: May 2013
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Childhood Central Nervous System (CNS) Tumor Survivors
Adolescent and young adult (AYA) survivors of childhood central nervous system (CNS) tumors in the United States (US).
Behavioral: Three-Factor Eating Questionnaire (TFEQ)-R18v2
Completion of TFEQ-R18v2 questionnaire.
Behavioral: Multifactor Screener
Completion of multifactor screener, a short assessment tool used to evaluate dietary intake of fruits, vegetables, percentage of energy from fat, and fiber.
Behavioral: Eating Questionnaire-EMA (EQ-EMA)
Completion of Eating Questionnaire-EMA (EQ-EMA).

Detailed Description:

A one-time assessment will be conducted for all participants through the Assessment Center website. No treatment or intervention will be provided. Two websites will be set up (Site A and Site B). The only difference between the two sites is the order that the questions will appear. The actual questions will remain the same. Only the adolescent and young adult (AYA) survivors of CNS tumors eligible after screening will be invited to respond to the survey. Following the final screening, the eligible participants will be randomized to Site A or Site B.

Each participant will complete the web-based questionnaire that has a total of 53 questions. For site A, the order of the questions will be TFEQ-R18v2, multifactor screener, and EQ-EMA. For site B, the order of the questions will be EQ-EMA, multifactor screener, and TFEQ-R18v2. The 53 questions came from the original TFEQ-R18v2, the multifactor screener used in the National Cancer Institute's Observing Protein and Energy Nutrition Study, and the adapted TFEQ-R18v2 for use via EMA methodology.

Multifactor screener is a short assessment tool used to evaluate dietary intake of fruits, vegetables, percentage of energy from fat, and fiber.

Eating Questionnaire-EMA (EQ-EMA) was adapted based on the original TFEQ-R18v2 for use via EMA methodology. The changes made were related to a change in verbiage to reflect our goal of assessing a participant's current behavior before and after an eating episode.

  Eligibility

Ages Eligible for Study:   15 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adolescent and young adult (AYA) males and females (15 to 39 years old) who survived childhood CNS tumors from MD Anderson Cancer Center, Texas Children's Cancer Center, and Web sources.

Criteria

Inclusion Criteria:

  1. Adolescent or Young Adult (AYA), 15 to 39 years old who has survived a primary CNS tumor
  2. Has been off therapy without relapse for at least 6 months
  3. Able to speak, write, and read in English
  4. Has access to the internet
  5. Has telephone access
  6. Currently lives in the United States

Exclusion Criteria:

  1. Is in foster care
  2. Is experiencing severe cognitive impairments that do not allow them to engage in basic conversations [We are 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 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.]
  3. Is incarcerated at the time of enrollment.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682824

Contacts
Contact: Karen Basen-Engquist, PHD, BA, MPH 713-745-3123
Contact: Maria Chang, MPH,RD,LD 713-794-1760 MChang1@mdanderson.org

Locations
United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Baylor College of Medicine
Texas Children's Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PHD, BA, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01682824     History of Changes
Other Study ID Numbers: 2012-0628
Study First Received: August 20, 2012
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
CNS tumor
Central Nervous System
CNS
Adolescent or Young Adult
AYA
Survivors
Eating Questionnaire-Ecological Momentary Assessment
EQ-EMA
Cognitive restraint
CR
Uncontrollable eating
UE
Three Factor Eating Questionnaire-R18v2
TFEQ-R18v2
Web-based questionnaire
Multifactor Screener

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014