A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 241
- 主要终点
- Feasibility of performing a test battery of neurocognitive and quality of life measures
研究概览
简要总结
RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the effects of the treatment and may help improve cancer treatment.
PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation therapy for brain metastases.
详细描述
OBJECTIVES: I. Determine the feasibility of performing a test battery consisting of five neurocognitive measures and a quality of life instrument following radiotherapy in patients with brain metastases.
OUTLINE: Patients undergo radiotherapy 5 days a week for 3 weeks. Quality of life and neurocognitive function is assessed before study, at completion of radiotherapy, and at 1 month after completion of radiotherapy. Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Histologically proven primary malignancy No primary site of hematopoietic origin (leukemia) No leptomeningeal involvement At least 1 measurable brain metastasis by CT or MRI
- •PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Neurological function classification 0-2 No major medical illnesses or psychiatric impairments that would preclude study
- •PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain Surgery: Not specified
排除标准
- 未提供
研究组 & 干预措施
Whole brain radiation therapy + neurocognitive assessments
Whole brain radiation therapy (WBRT) with neurocognitive assessments done pre and post WBRT.
干预措施: management of therapy complications (Procedure)
Whole brain radiation therapy + neurocognitive assessments
Whole brain radiation therapy (WBRT) with neurocognitive assessments done pre and post WBRT.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Feasibility of performing a test battery of neurocognitive and quality of life measures
时间窗: From registration to one month post radiation therapy
次要结局
未报告次要终点