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

NCT00533884 | Completed

• 3 other identifiers: CDR0000565963P30CA068485VU-VICC-SUPP-0751
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 4

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.

Conditions

Neurocognitive Impairment; Delirium; Esophageal Cancer; Head and Neck Cancer; Lung Cancer

Keywords

delirium; cognitive/functional effects; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; metastatic squamous neck cancer with occult primary; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; salivary gland cancer; esophageal cancer; non-small cell lung cancer; small cell lung cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• 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

• 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

Study Arms (1)

Treatment

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

Other: Assessment of therapy complications; Other: Neurocognitive assessment; Other: Quality-of-life assessment

Interventions

Assessment of therapy complications OTHER

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

Treatment

Neurocognitive assessment OTHER

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

Treatment

Quality-of-life assessment OTHER

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

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

MBCCOP - Meharry Medical College - Nashville

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Delirium; Esophageal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms; Nasopharyngeal Neoplasms; Oropharyngeal Neoplasms; Salivary Gland Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Mouth Diseases; Nasopharyngeal Diseases; Salivary Gland Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Stewart M. Bond, PhD, RN

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2013
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

US (4)