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Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: September 20, 2007   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00533884
  Purpose

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.


Condition Intervention
Cancer-Related Problem/Condition
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Procedure: cognitive assessment
Procedure: management of therapy complications
Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Head and Neck Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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
  • Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment

Secondary Outcome Measures:
  • Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT) at baseline
  • Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART) at baseline
  • Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Mood State measured by the Profile of Mood States (POMS-SF) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Overall quality of life measured using Cantril's Ladder at baseline and 3 months after completion of treatment
  • Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) at baseline and 3 months after completion of treatment
  • Hospitalizations, emergency department visits, and unscheduled clinic visits at each scheduled visit during treatment and at the 3-month post-treatment follow up
  • Falls, injuries, and other complications at each scheduled visit during treatment and at the 3-month post-treatment follow up

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533884

Locations
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville Recruiting
Nashville, Tennessee, United States, 37208
Contact: Contact Person     615-327-6000        
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Stewart M Bond     615-343-0035        
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Stewart M Bond     615-343-0035        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Stewart M. Bond, PhD, RN Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000565963, VU-VICC-SUPP-0751
Study First Received: September 20, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00533884     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
pulmonary carcinoid tumor

Study placed in the following topic categories:
Thoracic Neoplasms
Gastrointestinal Diseases
Laryngeal Carcinoma
Esophageal Neoplasms
Hypopharyngeal Cancer
Lip and Oral Cavity Cancer
Respiratory Tract Diseases
Lung Neoplasms
Salivary Gland Diseases
Delirium
Digestive System Neoplasms
Nasopharyngeal Carcinoma
Laryngeal Neoplasms
Esophageal Cancer
Oral Cancer
Carcinoma, Small Cell
Digestive System Diseases
Metastatic Squamous Neck Cancer With Occult Primary
Esophageal Disorder
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Non-small Cell Lung Cancer
Carcinoid Tumor
Esophageal Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Neoplasms
Digestive System Diseases
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009