Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
50 Years
N/A
Both
Malignant Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
Outcome Description:
To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.
Outcome Time Frame:
Baseline to 16 weeks after the start of chemotherapy
Safety Issue:
No
Principal Investigator
Julia Lawrence
Investigator Role:
Principal Investigator
Investigator Affiliation:
Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CCCWFU 99611
NCT ID:
NCT01506440
Start Date:
October 2011
Completion Date:
Related Keywords:
- Malignant Neoplasm
- Unspecified Adult Solid Tumor, Protocol Specific
- Neoplasms
Name | Location |
|---|---|
| Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
