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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00012 | Registry Identifier | NCI CTRP |
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The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors.
If you agree to take part in this study, the following tests and procedures will be performed:
The questionnaires will be given a code number and stored in a locked file cabinet at MD Anderson. No identifying information will be directly linked to your questionnaires. Only the researcher in charge of the study will have access to the code numbers and be able to link the questionnaires to you.
Length of Study:
After you have completed the blood draw, the computerized tasks, and the questionnaires, your participation on this study will be over.
Additional Information:
Any information about your symptoms that is collected as part of this study is for research purposes only. The questionnaires will only be used for the purposes of this study and will be destroyed after the study results have been reported.
If you describe a symptom as being severe on the symptom questionnaire, a study staff member will ask you if you have already told or plan to tell your doctor or nurse about the symptom. If you have not already told your doctor or nurse, a study staff member will tell your doctor or nurse about the symptom for you.
This is an investigational study.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. |
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| Low-Fatigue Head and Neck (HNC) Cancer Survivors | Other | Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Tasks | Behavioral | 3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Comparison in Male Head and Neck Cancer Survivors | Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Markers of Inflammation and Fatigue | Frequency of each COMT genotype (Val/Val; Met/Met; Val/Met) compared between high-fatigue and low-fatigue survivors. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Dantzer, DMV,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaires | Behavioral | Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires. |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |