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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00533884
First received: September 20, 2007
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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 Intervention
Neurocognitive Impairment
Delirium
Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Other: Assessment of therapy complications
Other: Neurocognitive assessment
Other: Quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall quality of life measured using Cantril's Ladder [ Time Frame: Baseline and 3 months post-treatment ] [ Designated as safety issue: No ]
  • Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) [ Time Frame: Baseline and 3 months post-treatment ] [ Designated as safety issue: No ]
  • Hospitalizations, emergency department visits, and unscheduled clinic visits [ Time Frame: At each scheduled treatment visit and 3 months post-treatment ] [ Designated as safety issue: No ]
  • Falls, injuries, and other complications [ Time Frame: At each scheduled treatment visit and 3 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: October 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment
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

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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533884

Locations
United States, Tennessee
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Chair: Stewart M. Bond, PhD, RN Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Stewart M. Bond, PhD, RN (Principal Investigator), Vanderbilt University
ClinicalTrials.gov Identifier: NCT00533884     History of Changes
Other Study ID Numbers: CDR0000565963, P30CA068485, VU-VICC-SUPP-0751
Study First Received: September 20, 2007
Last Updated: August 2, 2011
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
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

Additional relevant MeSH terms:
Delirium
Esophageal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive 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

ClinicalTrials.gov processed this record on July 10, 2014