Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Health Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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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辅助研究
其他名称：
Given cognitive assessments
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
大体时间：Baseline to 16 weeks after the start of chemotherapy
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To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.
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Baseline to 16 weeks after the start of chemotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in cognition over time
大体时间：Baseline to 16 weeks after the start of chemotherapy
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As measured by cognitive assessment instruments
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Baseline to 16 weeks after the start of chemotherapy
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Association of cognitive performance with performance status and adverse events (AE)
大体时间：Baseline to 16 weeks after the start of chemotherapy
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Baseline to 16 weeks after the start of chemotherapy
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合作者和调查者
调查人员
- 首席研究员：Heidi Klepin, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00018421
- NCI-2011-03034 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- CCCWFU 99611 (其他标识符：Wake Forest University Health Sciences)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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