Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Wake Forest University (WFU)

Status: Completed

Conditions: Malignant Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Procedure: quality-of-life assessment; Procedure: cognitive assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01506440

NCI-2011-03034 (Registry Identifier)

IRB00018421

CCCWFU 99611 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

Supportive Care (cognitive assessment)

Description:

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.

Treatment:

Procedure: cognitive assessment

Procedure: quality-of-life assessment