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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03034 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 99611 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive assessment | Procedure | Given cognitive assessments |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being treated for the first time using standard chemotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| quality-of-life assessment |
| Procedure |
Ancillary studies |
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| Baseline to 16 weeks after the start of chemotherapy |