Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Study Overview
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Brief Summary
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This pilot clinical trial studies cognitive assessments in patients with cancer undergoing chemotherapy. Questionnaires that measure cognitive changes during chemotherapy may help identify the side effects of chemotherapy.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic. SECONDARY OBJECTIVES: I. To estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy. II. To explore the association of cognitive performance with the Eastern Cooperative Oncology Group (ECOG) performance status as evaluated by the patient's oncology team. III. To assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy. OUTLINE: Patients complete cognitive assessments, comprising Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test Parts A & B (TMT-A, TMT-B), Digit Symbol Coding Test (DSC), Category Fluency Test (Animals), Montreal Cognitive Assessment (MoCA), and Digit Span Test (DST). Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.

Official Title
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Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients

Conditions
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Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: cognitive assessment
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically or cytologically confirmed cancer Patients are candidates for systemic chemotherapy for their cancer diagnosis Life expectancy must be greater than 6 months Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients who have had prior systemic chemotherapy in their lifetime Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Patients may not be participating on any other study investigating cognitive function Patients who are non-English speaking are ineligible Patients with hematologic malignancies are ineligible Patients with primary central nervous system malignancies are ineligible

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supportive Care (cognitive assessment)<br>Patients complete cognitive assessments, comprising HVLT-R, TMT-A, TMT-B, DSC, Animals, MoCA, and DST. Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy. | Procedure: cognitive assessment<br>* Given cognitive assessments<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy. | To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices. | Baseline to 16 weeks after the start of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognition over time | As measured by cognitive assessment instruments | Baseline to 16 weeks after the start of chemotherapy | 
| Association of cognitive performance with performance status and adverse events (AE) |  | Baseline to 16 weeks after the start of chemotherapy |