Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: cognitive assessment
Procedure: quality-of-life assessment
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients|
- 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 ] [ Designated as safety issue: No ]To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.
- Changes in cognition over time [ Time Frame: Baseline to 16 weeks after the start of chemotherapy ] [ Designated as safety issue: No ]As measured by cognitive assessment instruments
- Association of cognitive performance with performance status and adverse events (AE) [ Time Frame: Baseline to 16 weeks after the start of chemotherapy ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
Procedure: cognitive assessment
Given cognitive assessmentsProcedure: quality-of-life assessment
Other Name: quality of life assessment
I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506440
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heidi Klepin, MD||Wake Forest School of Medicine|