Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506440
• Other study ID #: IRB00018421
• Secondary ID: NCI-2011-03034CC
• Status: Completed
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• cognitive assessment
Given cognitive assessments
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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