Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01506440|
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment|
|Malignant Neoplasm Unspecified Adult Solid Tumor, Protocol Specific||Procedure: cognitive assessment Procedure: 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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients|
|Actual Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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 assessments
Procedure: quality-of-life assessment
Other Name: quality of life assessment
- 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 ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506440
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heidi Klepin, MD||Wake Forest University Health Sciences|