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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-SUPP-0751 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.
Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.
Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Patients undergoing treatment for head and neck, lung, and esophagus cancers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of therapy complications | Other | Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Domain-Specific Neurocognitive Functioning measuring attention, executive functioning, mental processing speed, verbal memory, language, and visuospatial construction at baseline and 3 months after completion of treatment | Baseline and 3 months post-treatment | |
| Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment | |
| Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile | Baseline, at each scheduled treatment visit, and at 3 months post-treatment | |
| Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT) | Baseline | |
| Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART) | Baseline |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)
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| Name | Affiliation | Role |
|---|---|---|
| Stewart M. Bond, PhD, RN | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
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| Neurocognitive assessment | Other | Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency |
|
| Quality-of-life assessment | Other | Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment |
|
| Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale | Baseline, at each scheduled treatment visit, and at 3 months post-treatment |
| Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment |
| Mood State measured by the Profile of Mood States (POMS-SF) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment |
| Overall quality of life measured using Cantril's Ladder | Baseline and 3 months post-treatment |
| Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) | Baseline and 3 months post-treatment |
| Hospitalizations, emergency department visits, and unscheduled clinic visits | At each scheduled treatment visit and 3 months post-treatment |
| Falls, injuries, and other complications | At each scheduled treatment visit and 3 months post-treatment |
| Nashville |
| Tennessee |
| 37064 |
| United States |
| MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee | 37208 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D007012 | Hypopharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D009062 | Mouth Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D012468 | Salivary Gland Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D009059 | Mouth Diseases |
| D009302 | Nasopharyngeal Diseases |
| D012466 | Salivary Gland Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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