Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

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

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.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Malignant Neoplasm
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: cognitive assessment

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients being treated for the first time using standard chemotherapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Supportive Care (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.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Procedure: cognitive assessment; Given cognitive assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Heidi Klepin, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB00018421; NCI-2011-03034 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 99611 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No