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Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers


N/A
21 Years
N/A
Open (Enrolling)
Both
Neurocognitive Impairment, Delirium, Esophageal Cancer, Head and Neck Cancer, Lung Cancer

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Trial Information

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome 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

Outcome Time Frame:

Baseline and 3 months post-treatment

Safety Issue:

No

Principal Investigator

Stewart M. Bond, PhD, RN

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000565963

NCT ID:

NCT00533884

Start Date:

October 2007

Completion Date:

October 2012

Related Keywords:

  • Neurocognitive Impairment
  • Delirium
  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • 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
  • Delirium
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064