Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
I. To assess the feasibility of administering a cognitive assessment battery in a medical
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.
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.
Observational Model: Case-Only, Time Perspective: Prospective
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
Wake Forest University
United States: Institutional Review Board
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