NCT04277650已完成不适用
System for High Intensity EvaLuation During Radiation Therapy (SHIELD-RT): A Prospective Randomized Study of Machine Learning-directed Clinical Evaluations During Outpatient Cancer Radiation and Chemoradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Number of unplanned emergency department visits or hospital admissions
研究概览
简要总结
This quality improvement project will evaluate the implementation of a previously described intervention (twice per week on-treatment clinical evaluations) in a feasible fashion using a previously described machine learning algorithm identifying patients identified at high risk for an emergency visit or hospitalization during radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The ML directed twice-weekly evaluation arm was unblinded. Participants and providers were blinded to ML identification of high risk participants in the once weekly evaluation (standard of care) arm.
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
- •started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center
排除标准
- •undergoing total body radiation therapy for hematopoetic stem cell transplantation
- •undergoing therapy as inpatient
- •treating physician who opted out of randomization
- •completed radiation therapy prior to algorithm execution
结局指标
主要结局
Number of unplanned emergency department visits or hospital admissions
时间窗: 6 months
次要结局
- Number of missed clinical evaluation visits(6 months)
- Number of acute care visits with listed reason as anemia, nutrition (including dehydration), diarrhea, emesis, infectious (including fever, pneumonia, and sepsis), nausea, neutropenia, pain category(6 months)
- Number of unplanned emergency department visits or hospital admissions up to 15 days post radiation treatment(up to 15 days post radiation treatment)
研究者
研究点 (2)
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