Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
时间窗: 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.
次要结局
- Changes in cognition over time(Baseline to 16 weeks after the start of chemotherapy)
- Association of cognitive performance with performance status and adverse events (AE)(Baseline to 16 weeks after the start of chemotherapy)