Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cognitive outcomes
研究概览
简要总结
This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.
详细描述
PRIMARY OBJECTIVE:
I. Record patients' cognitive outcomes after whole-brain radiation therapy (WBRT) for hematologic malignancies using standard-of-care neurocognitive function testing.
SECONDARY OBJECTIVES:
I. Assess patients' quality-of-life after WBRT for hematologic malignancies, based on a validated questionnaire.
II. Explore magnetic resonance imaging (MRI) changes in the brain after WBRT for hematologic malignancies, based on standard-of-care imaging studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma [PCNSL], secondary central nervous system lymphoma [SCNSL], leukemia, myeloma)
- •Proficient and capable of completing tests in English
- •Patients with claustrophobia are eligible if the claustrophobia is managed with medication
- •Patients with cognitively-impairment are eligible if the impairment is managed with medication
- •Patients who are pregnant
排除标准
- 未提供
结局指标
主要结局
Cognitive outcomes
时间窗: Up to 5 years
Neurocognitive failure will be defined as the first cognitive failure on 2 or more of the following tests: the Hopkins Verbal Learning Test Revised Total Recall, Delayed Recall and Delayed Recognition; the Controlled Oral Word Association; and the Trail Making Test Part A or B. The rate of neurocognitive failure and its 95% confidence interval (CI) will be calculated. The cumulative incidence approach may be used to estimate the median time to neurocognitive failure to account for the competing risk of death. May use the Aalen-Johansen estimator of the cumulative incidence function.
次要结局
- Quality-of-life(Up to 5 years)
- Magnetic resonance imaging (MRI) changes(Baseline up to 5 years)
- Role of medications indicated to improve memory and cognitive function(Up to 5 years)