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临床试验/NCT03211806
NCT03211806已完成不适用

Technology to Reduce Sedentary Behavior Before and After Cancer Surgery

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年6月6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
26
试验地点
2
主要终点
Adherence

研究概览

简要总结

The goal of this research is to develop and test a technology-supported intervention to reduce sedentary behavior before and after cancer surgery. Surgical oncology patients are at elevated risk for postoperative complications and readmissions. Sedentary behavior increases markedly after surgery and hospitalization, and reducing sedentary behavior around the time of cancer surgery could reduce risk while also empowering cancer patients to take a more active role in their recovery.

详细描述

Colorectal or peritoneal cancer patients scheduled for surgical resection (n=60) will be randomized to either the sedentary behavior intervention or monitoring only. The intervention will use a Bluetooth-enabled activity monitor to detect prolonged sedentary bouts, which will prompt a message delivered via smartphone suggesting that patients walk. The intervention will begin at least two weeks prior to scheduled surgery and will continue through the first 30 days at home following hospital discharge. Outcomes will include objective activity and sedentary behavior, patient-reported symptoms and quality of life using standardized instruments, inflammatory biomarkers, and morbidity and hospital readmission 30-days after index discharge.

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

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

  • Scheduled for curative surgical treatment of metastatic colorectal or peritoneal cancer at UPMC Shadyside
  • Ability to stand and walk unassisted prior to surgery
  • Identified at least two weeks prior to their scheduled surgery date

排除标准

  • Unable to read and write in English

结局指标

主要结局

Adherence

时间窗: 30-days post-discharge

Percentages of assessments completed and prompts after which steps were detected

Retention

时间窗: 30 days post-discharge

Percentage of those enrolled who completed the program

Acceptability

时间窗: 30-days post-discharge

Post-intervention interviews will be conducted to assess acceptability of the program

次要结局

  • Objective physical activity(Change from baseline to 30 days post-discharge)
  • Morbidity(30 days post-discharge)
  • Total objective sedentary behavior(Change from baseline to 30 days post-discharge)
  • Mean sedentary behavior bout(Change from baseline to 30 days post-discharge)
  • Patient-reported quality of life(Change from baseline to 30 days post-discharge)
  • Readmission(30 days post-discharge)
  • Patient-reported symptoms(Change from baseline to 30 days post-discharge)
  • Inflammatory biomarkers(2 weeks post-discharge)
  • Maximum sedentary behavior bout(Change from baseline to 30 days post-discharge)

研究者

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

Carissa Low

Assistant Professor

University of Pittsburgh

研究点 (2)

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