Full Text View
Tabular View
No Study Results Posted
Related Studies
Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
This study is currently recruiting participants.
Study NCT00533884   Information provided by National Cancer Institute (NCI)
First Received: September 20, 2007   Last Updated: August 11, 2009   History of Changes

September 20, 2007
August 11, 2009
October 2007
March 2009   (final data collection date for primary outcome measure)
  • 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
  • Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
Same as current
Complete list of historical versions of study NCT00533884 on ClinicalTrials.gov Archive Site
  • Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT) at baseline
  • Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART) at baseline
  • Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Mood State measured by the Profile of Mood States (POMS-SF) at baseline, at each scheduled treatment visit, and at 3 months after completion of treatment
  • Overall quality of life measured using Cantril's Ladder at baseline and 3 months after completion of treatment
  • Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) at baseline and 3 months after completion of treatment
  • Hospitalizations, emergency department visits, and unscheduled clinic visits at each scheduled visit during treatment and at the 3-month post-treatment follow up
  • Falls, injuries, and other complications at each scheduled visit during treatment and at the 3-month post-treatment follow up
Same as current
 
Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

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.

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.

 
Observational
 
  • Cognitive/Functional Effects
  • Delirium
  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Procedure: assessment of therapy complications
  • Procedure: cognitive assessment
  • Procedure: quality-of-life assessment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
March 2009   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
 
United States
 
NCT00533884
 
CDR0000565963, VU-VICC-SUPP-0751
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Stewart M. Bond, PhD, RN Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP