Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment. To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment. To describe how neurocognitive functioning changes over time during cancer treatment. Secondary To identify sociodemographic and clinical factors associated with neurocognitive impairment. To examine health-related outcomes associated with neurocognitive impairment. 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.

Official Title
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Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Conditions
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Neurocognitive Impairment, Delirium, Esophageal Cancer, Head and Neck Cancer, Lung Cancer

Intervention / Treatment
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* Other: Assessment of therapy complications
* Other: Neurocognitive assessment
* Other: Quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center No known brain metastasis PATIENT CHARACTERISTICS: Able to hear, speak, and understand English No prior diagnosis of other cancer except basal cell carcinoma PRIOR CONCURRENT THERAPY: No treatment plans including prophylactic cranial irradiation

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br>Patients undergoing treatment for head and neck, lung, and esophagus cancers | Other: Assessment of therapy complications<br>* Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations<br>Other: Neurocognitive assessment<br>* Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency<br>Other: Quality-of-life assessment<br>* Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, cognitive/functional effects, hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, metastatic squamous neck cancer with occult primary, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, salivary gland cancer, esophageal cancer, non-small cell lung cancer, small cell lung cancer