Overview

This trial is active, not recruiting.

Conditions malignant neoplasm, unspecified adult solid tumor, protocol specific
Treatments cognitive assessment, quality-of-life assessment
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date October 2012
Trial size 25 participants
Trial identifier NCT01506440, CCCWFU 99611, NCI-2011-03034

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
cognitive assessment
Given cognitive assessments
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
time frame: Baseline to 16 weeks after the start of chemotherapy

Secondary Outcomes

Measure
Changes in cognition over time
time frame: Baseline to 16 weeks after the start of chemotherapy
Association of cognitive performance with performance status and adverse events (AE)
time frame: Baseline to 16 weeks after the start of chemotherapy

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
Principal investigator Heidi Klepin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in September 2016.