Clinical trial NCT00533884: Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
Official title: Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Impairment
Delirium
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Keywords: 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
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-09-24
Enrollment: 86
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and 3 months post-treatment
measure: Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
measure: Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
measure: Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Secondary outcomes:
measure: Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline
measure: Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
timeFrame: Baseline
measure: Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
measure: Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF)
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
measure: Mood State measured by the Profile of Mood States (POMS-SF)
timeFrame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
measure: Overall quality of life measured using Cantril's Ladder
timeFrame: Baseline and 3 months post-treatment
measure: Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
timeFrame: Baseline and 3 months post-treatment
measure: Hospitalizations, emergency department visits, and unscheduled clinic visits
timeFrame: At each scheduled treatment visit and 3 months post-treatment
measure: Falls, injuries, and other complications
timeFrame: At each scheduled treatment visit and 3 months post-treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: MBCCOP - Meharry Medical College - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Stewart M. Bond, PhD, RN
role: STUDY_CHAIR
References: