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临床试验/NCT04314778
NCT04314778已完成不适用

Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery for Cancer

University of Pennsylvania4 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
4
主要终点
Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge

研究概览

简要总结

This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program.

详细描述

We will conduct a two-arm randomized, controlled trial during the postoperative period after a radical cystectomy for bladder cancer, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled after being diagnosed with bladder cancer and scheduled to undergo a radical cystectomy. The median length of stay after a radical cystectomy is 8 days, with 90% being discharged within two weeks. Postoperatively, the baseline step count will be averaged by taking the steps taken during the first two days outside of the intensive care unit. There will be two postoperative phases: Phase I will be while the patient is hospitalized postoperatively. Phase II will be when the patient is discharged for three months.

5.2 Study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • diagnosis of cancer undergoing definitive surgical treatment

排除标准

  • Inability to provide consent
  • does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them
  • any other medical conditions that would prohibit participation in a physical activity program

结局指标

主要结局

Change in Mean Daily Step Count From the Baseline Step Count During Two Days After the Surgery to the Hospital Discharge

时间窗: From baseline step count after a two-day run-in period after the surgery to the time of hospital discharge postoperatively. As the time to discharge was variable, this time period was up to 60 days after surgery

Change in mean daily step count

次要结局

  • Change in Mean Daily Step Count From the Postoperative Baseline to 3 Months After Discharge From the Hospital(From the postoperative baseline step count during 2 day run-in to 3 months after discharge from the hospital. This time was up to 3 months after discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Lee, MD, MS

Principal Investigator

University of Pennsylvania

研究点 (4)

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