Overview

This trial is active, not recruiting.

Conditions neurocognitive impairment, delirium, esophageal cancer, head and neck cancer, lung cancer
Treatments assessment of therapy complications, neurocognitive assessment, quality-of-life assessment
Sponsor Vanderbilt University
Collaborator National Cancer Institute (NCI)
Start date October 2007
End date May 2010
Trial size 100 participants
Trial identifier NCT00533884, CDR0000565963, P30CA068485, VU-VICC-SUPP-0751

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients undergoing treatment for head and neck, lung, and esophagus cancers
assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

Primary Outcomes

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
time frame: Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
time frame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
time frame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
time frame: Baseline, at each scheduled treatment visit, and at 3 months post-treatment

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by Vanderbilt University.