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

Completed

• Conditions: Esophageal Cancer; Head and Neck Cancer; Lung Cancer; Neurocognitive Impairment; Delirium
• Interventions: Other: Assessment of therapy complications; Other: Neurocognitive assessment; Other: Quality-of-life assessment

• Registration Number: NCT00533884
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Study Start: 2007-10
• Primary Completion: 2010-05
• Study Completion: 2013-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Assessment of therapy complications	Patients undergoing treatment for head and neck, lung, and esophagus cancers
Treatment	Quality-of-life assessment	Patients undergoing treatment for head and neck, lung, and esophagus cancers
Treatment	Neurocognitive assessment	Patients undergoing treatment for head and neck, lung, and esophagus cancers

Primary Outcome Measures

Name	Time	Method
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	Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)	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	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)	Baseline, at each scheduled treatment visit, and at 3 months post-treatment

Secondary Outcome Measures

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

Trial Locations

Locations (4)

MBCCOP - Meharry Medical College - Nashville; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center - Cool Springs; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States