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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00533884

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

21.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurocognitive Impairment Delirium Esophageal Cancer Head and Neck Cancer Lung Cancer	Other: Assessment of therapy complications Other: Neurocognitive assessment Other: Quality-of-life assessment

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.

Study Design

Study Type:

Observational

Actual Enrollment :

86 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 [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 Outcome Measures

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]
Overall quality of life measured using Cantril's Ladder [Baseline and 3 months post-treatment]
Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC) [Baseline and 3 months post-treatment]
Hospitalizations, emergency department visits, and unscheduled clinic visits [At each scheduled treatment visit and 3 months post-treatment]
Falls, injuries, and other complications [At each scheduled treatment visit and 3 months post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee	United States	37064
2	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee	United States	37064
3	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee	United States	37208
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838