Lung Cancer Clinical Trial
Official title:
Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers
Verified date | April 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | June 2013 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment | ||
Primary | 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 | ||
Primary | 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 | Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT) | Baseline | ||
Secondary | Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART) | Baseline | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Mood State measured by the Profile of Mood States (POMS-SF) | Baseline, at each scheduled treatment visit, and at 3 months post-treatment | ||
Secondary | Overall quality of life measured using Cantril's Ladder | Baseline and 3 months post-treatment | ||
Secondary | Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) | Baseline and 3 months post-treatment | ||
Secondary | Hospitalizations, emergency department visits, and unscheduled clinic visits | At each scheduled treatment visit and 3 months post-treatment | ||
Secondary | Falls, injuries, and other complications | At each scheduled treatment visit and 3 months post-treatment |
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