Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Completed

• Conditions: Malignant Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Procedure: cognitive assessment; Procedure: quality-of-life assessment

• Registration Number: NCT01506440
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-21
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Supportive Care (cognitive assessment)	quality-of-life assessment	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.
Supportive Care (cognitive assessment)	cognitive assessment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in cognition over time	Baseline to 16 weeks after the start of chemotherapy	As measured by cognitive assessment instruments
Association of cognitive performance with performance status and adverse events (AE)	Baseline to 16 weeks after the start of chemotherapy

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States