NCT01506440

Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Malignant Neoplasm
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
PROCEDURE	cognitive assessment	Given cognitive assessments
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-01-10
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States