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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00533884 |
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 |
Study Type: | Observational |
Official Title: | Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers |
Estimated Enrollment: | 100 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Stewart M. Bond, PhD, RN | Vanderbilt-Ingram Cancer Center |
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 |
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 |
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 |
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 |