Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 86
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- 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)