Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
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|ClinicalTrials.gov Identifier: NCT00533884|
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : April 7, 2017
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 or disease||Intervention/treatment|
|Neurocognitive Impairment Delirium Esophageal Cancer Head and Neck Cancer Lung Cancer||Other: Assessment of therapy complications Other: Neurocognitive assessment Other: Quality-of-life assessment|
- 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.
- 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 Type :||Observational|
|Actual Enrollment :||86 participants|
|Official Title:||Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||June 2013|
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
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533884
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center at Franklin|
|Nashville, Tennessee, United States, 37064|
|MBCCOP - Meharry Medical College - Nashville|
|Nashville, Tennessee, United States, 37208|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Stewart M. Bond, PhD, RN||Vanderbilt-Ingram Cancer Center|