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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
Health authority
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

Study Design


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
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