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

Lung Cancer Clinical Trial

Official title:

Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533884
• Other study ID #: CDR0000565963
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: September 20, 2007
• Last updated: April 5, 2017
• Start date: October 2007
• Est. completion date: June 2013

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2013
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Esophageal Cancer
• Esophageal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms
• Neurocognitive Impairment

Intervention

Other:
• Assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
• Neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
• Quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

Locations

Country	Name	City	State
United States	MBCCOP - Meharry Medical College - Nashville	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)		Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Primary	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
Primary	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	Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)		Baseline
Secondary	Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)		Baseline
Secondary	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
Secondary	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
Secondary	Mood State measured by the Profile of Mood States (POMS-SF)		Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Secondary	Overall quality of life measured using Cantril's Ladder		Baseline and 3 months post-treatment
Secondary	Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)		Baseline and 3 months post-treatment
Secondary	Hospitalizations, emergency department visits, and unscheduled clinic visits		At each scheduled treatment visit and 3 months post-treatment
Secondary	Falls, injuries, and other complications		At each scheduled treatment visit and 3 months post-treatment