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

September 20, 2007
August 2, 2011
October 2007
May 2010   (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 [ 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 ]
Not Provided
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) [ 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 ]
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Neurocognitive Impairment
  • Delirium
  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • 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
Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
Interventions:
  • Other: Assessment of therapy complications
  • Other: Neurocognitive assessment
  • Other: Quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
October 2012
May 2010   (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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533884
CDR0000565963, P30CA068485, VU-VICC-SUPP-0751
No
Stewart M. Bond, PhD, RN (Principal Investigator), Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Stewart M. Bond, PhD, RN Vanderbilt-Ingram Cancer Center
Vanderbilt University
August 2011

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