Beyond Performance Status: Electronic Activity Monitoring to Assess Functional Activity of Patients With Gastrointestinal Malignancy During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy
研究概览
简要总结
Electronic activity monitoring (EAM) devices are wearable electronic devices that monitor functional activity and provide personal feedback on activity progression. This study aims to determine if EAM can provide an objective, assessment of patient functional activity. The study will also examine the change in functional activity experienced by patients during the first cycle of chemotherapy. Another objective of the study will be to see if baseline functional activity and the change in functional activity that occurs during the first cycle of chemotherapy can be used to predict patient tolerability of subsequent cycles of chemotherapy.
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
- •Clinical diagnosis of gastrointestinal malignancy.
- •Age ≥ 18 years
- •Planned to receive systemic chemotherapy, either adjuvant chemotherapy, or neoadjuvant chemotherapy, or any new line of chemotherapy in the setting of advanced disease. Subjects may enroll prior to chemotherapy or during the first cycle of treatment.
排除标准
- •Restricted mobility defined as dependence or anytime use of a walker or wheelchair in the past three months.
- •Refusing systemic chemotherapy.
- •Concurrent radiotherapy with chemotherapy
- •Have received at least one cycle of chemotherapy in the current chemotherapy regimen.
结局指标
主要结局
EAM Max Step-count On-Chemotherapy - EAM Max Step-count Pre-Chemotherapy
时间窗: 1 year
change in physical activity between pre-chemotherapy and on-chemotherapy by counting the steps
次要结局
未报告次要终点