Clinical trial NCT01506440: Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Official title: Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-10
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated for the first time using standard chemotherapy

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
timeFrame: Baseline to 16 weeks after the start of chemotherapy
Secondary outcomes:
measure: Changes in cognition over time
timeFrame: Baseline to 16 weeks after the start of chemotherapy
measure: Association of cognitive performance with performance status and adverse events (AE)
timeFrame: Baseline to 16 weeks after the start of chemotherapy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Klepin, MD
role: PRINCIPAL_INVESTIGATOR
References: