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Completed

NCT Number: NCT00533884

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

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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Key information

Conditions

Neurocognitive Impairment Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Confusion Delirium Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Diseases Laryngeal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Mental Disorders Mouth Diseases Mouth Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Signs and Symptoms Small Cell Lung Carcinoma Stomatognathic Diseases Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MBCCOP - Meharry Medical College - Nashville, Nashville, Tennessee, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

assessment of therapy complications

Other

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

Neurocognitive Assessment

Other

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

Quality-of-Life Assessment

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: Baseline

  2. Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)

    Time frame: Baseline

  3. 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

  4. 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

  5. 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

  6. Overall quality of life measured using Cantril's Ladder

    Time frame: Baseline and 3 months post-treatment

  7. Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)

    Time frame: Baseline and 3 months post-treatment

  8. Hospitalizations, emergency department visits, and unscheduled clinic visits

    Time frame: At each scheduled treatment visit and 3 months post-treatment

  9. Falls, injuries, and other complications

    Time frame: At each scheduled treatment visit and 3 months post-treatment

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Sep 24, 2007
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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