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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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

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Neurocognitive Impairment Delirium Esophageal Cancer Head and Neck Cancer Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Patients undergoing treatment for head and neck, lung, and esophagus cancers

Assessment of therapy complications

Intervention Type OTHER

Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations

Neurocognitive assessment

Intervention Type OTHER

Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency

Quality-of-life assessment

Intervention Type OTHER

Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

Interventions

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Assessment of therapy complications

Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations

Intervention Type OTHER

Neurocognitive assessment

Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency

Intervention Type OTHER

Quality-of-life assessment

Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No