NCT01682824

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

May 17, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

8.7 years

First QC Date

August 20, 2012

Last Update Submit

February 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group I (questionnaire, nutritional assessment)

Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online.

Other: Nutritional AssessmentOther: Questionnaire Administration

Group II (questionnaire, nutritional assessment)

Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire.

Other: Nutritional AssessmentOther: Questionnaire Administration

Interventions

Complete dietary intake assessment

Also known as: Dietary Assessment, dietary counseling, nutritional counseling
Group I (questionnaire, nutritional assessment)Group II (questionnaire, nutritional assessment)

Complete TFEQ-R18v2 questionnaire

Group I (questionnaire, nutritional assessment)Group II (questionnaire, nutritional assessment)

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

MDACC participants

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Karen Basen-Engquist

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2012

First Posted

September 11, 2012

Study Start

May 17, 2013

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

February 3, 2022

Record last verified: 2022-02

Locations