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| Sponsor: | Vanderbilt University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Vanderbilt University |
| 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 |
|---|---|
|
Neurocognitive Impairment Delirium Esophageal Cancer Head and Neck Cancer Lung Cancer |
Other: Assessment of therapy complications Other: Neurocognitive assessment Other: Quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | October 2012 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
|
Other: Assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
Other: Neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
Other: Quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Tennessee | |
| MBCCOP - Meharry Medical College - Nashville | |
| Nashville, Tennessee, United States, 37208 | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| Study Chair: | Stewart M. Bond, PhD, RN | Vanderbilt-Ingram Cancer Center |
More Information
| Responsible Party: | Stewart M. Bond, PhD, RN (Principal Investigator), Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00533884 History of Changes |
| Other Study ID Numbers: | CDR0000565963, P30CA068485, VU-VICC-SUPP-0751 |
| Study First Received: | September 20, 2007 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Federal Government |
|
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 Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |