NCT00533884

Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-05-01
• Completion: 2013-06-01
• First posted: 2007-09-24
• Last updated: 2017-04-07

Locations

4 sites across 1 country: United States