Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Wake Forest University Health Sciences29 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Malignant Neoplasm Unspecified Adult Solid Tumor, Protocol Specific

Interventions

cognitive assessmentPROCEDURE

Given cognitive assessments

quality-of-life assessmentPROCEDURE

Ancillary studies

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 16 weeks after the start of chemotherapy

Secondary Outcomes

Changes in cognition over time

As measured by cognitive assessment instruments

Time frame: Baseline to 16 weeks after the start of chemotherapy

Association of cognitive performance with performance status and adverse events (AE)

Time frame: Baseline to 16 weeks after the start of chemotherapy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.