Cancer SurvivorNCT01682824
Three-Factor Eating Questionnaire in Measuring Eating Behavior in Adolescent and Young Adult Survivors of CNS Tumors
An observational study of Cancer Survivor, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Cancer Survivor
- What is being tested?
- Nutritional Assessment and Questionnaire Administration
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2013to 24 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: MDACC participants
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors
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.
Read the 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.
- Conditions
- Cancer Survivor
- Being tested
- Nutritional Assessment, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Complete dietary intake assessment
Questionnaire AdministrationOther
Complete TFEQ-R18v2 questionnaire
Questionnaire AdministrationOther
Complete EQ-EMA questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group I (questionnaire, nutritional assessment) | Patients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online. Receives: Other: Nutritional Assessment; Other: Questionnaire Administration | |
| Group II (questionnaire, nutritional assessment) | Patients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire. Receives: Other: Nutritional Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study start17 May 2013
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682824
- Sponsor's protocol ID
- 2012-0628
- Other IDs
- NCI-2018-02536, 2012-0628
- Status last verified
- Feb 2022
- First submitted
- 20 Aug 2012
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyChoice: An Application of the Three-Factor Eating Questionnaire (TFEQ-R18v2) Among Adolescent and Young Adult Survivors of CNS Tumors
- ClinicalTrials.gov ID
- NCT01682824
- Acronym / sponsor ID
- 2012-0628
- Conditions
- Cancer Survivor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 May 2013 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (questionnaire, nutritional assessment) | – | Other: Nutritional Assessment, Other: Questionnaire AdministrationPatients complete the TFEQ-R18v2 questionnaire, a dietary intake assessment, and the EQ-EMA questionnaire online. |
| Group II (questionnaire, nutritional assessment) | – | Other: Nutritional Assessment, Other: Questionnaire AdministrationPatients complete the EQ-EMA questionnaire, a dietary intake assessment and the TFEQ-R18v2 questionnaire. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- MDACC participants
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingComplete dietary intake assessment | Other | Group I (questionnaire, nutritional assessment), Group II (questionnaire, nutritional assessment) |
| Questionnaire AdministrationComplete TFEQ-R18v2 questionnaire | Other | Group I (questionnaire, nutritional assessment), Group II (questionnaire, nutritional assessment) |
| Questionnaire AdministrationComplete EQ-EMA questionnaire | Other | Group I (questionnaire, nutritional assessment), Group II (questionnaire, nutritional assessment) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Basen-Engquist principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Similarity of factor structures between the Eating Questionnaire (EQ-EMA) and the Three-Factor Eating Questionnaire (TFEQ-R18v2) (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.