Precision Performance Status Compared With ECOG Performance Status- A Pilot Cross Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Median acceleration at the Spine Base and non-pivoting leg
研究概览
简要总结
This study compares consumer movement trackers to the Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) in monitoring cancer patient movement. The ECOG PS emphasizes a patient's ambulatory status (ability to walk around), and scores patients on a scale of 0-5: 0 (no restrictions), 1 (ambulatory), 2 (< 50% of hours spent in bed, unable to carry out work activities), 3 (> 50% of hours spent in bed, limited in self care), 4 (bedbound and gravely disabled) and 5 (deceased). Accurate assessment of a patient's PS is paramount in informing therapeutic decision-making, whether it be to predict response and tolerability to treatment or determine eligibility for clinical trials. However, the ECOG PS scale is observational, and therefore limited in its precision. Information gained in this study may help researchers learn if there is a better way to assess patient movement with computerized analysis tools using movement trackers.
详细描述
PRIMARY OBJECTIVE:
I. To determine the correlation between patient acceleration of the spine base/non-pivoting leg captured with in-office movement trackers, and physician/patient assessed Eastern Cooperative Oncology Group (ECOG) performance status (PS) using a Microsoft Kinect movement tracker.
SECONDARY OBJECTIVES:
I. To determine the correlation between clinician/patient assessed ECOG PS and Kinect assessed ECOG PS score.
II. To determine the range of measured patient acceleration measurements for each ECOG score between 0 and 3.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •A diagnosis of cancer
- •Age >= 18 years
- •Ability to understand and the willingness to sign a written informed consent
- •Able to ambulate without an assistive device
排除标准
- •Missing lower limbs
- •Known movement disorder such as Parkinson's disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
结局指标
主要结局
Median acceleration at the Spine Base and non-pivoting leg
时间窗: Day 1
The Kinect device will record the participant performing the chair to examination table activity and the Get up and Go activity. This recording will quantify spine and non-pivoting leg mean acceleration during movement onto an examination table and the Get up and Go time. These values will be assessed for a linear or monotonic relationship with Eastern Cooperative Oncology Group (ECOG) scores. If a linear relationship is exhibited the primary objective will be evaluated via a Pearson correlation coefficient. However, the supposition is the data will more likely reflect a monotonic relationship. In this event the primary objective will be evaluated via a Kendall Rank Tau-b correlation coefficient.
次要结局
- Video recording assessed ECOG Performance Status (PS) measurement(Baseline)