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临床试验/NCT01807390
NCT01807390Unknown不适用

Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Change in pain perceptions

研究概览

简要总结

This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system.

Hypotheses:

  1. The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure.
  2. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery.
  3. Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.

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

入选标准

  • Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point)

排除标准

  • Below 18 years of age.

结局指标

主要结局

Change in pain perceptions

时间窗: Baseline, 4 weeks and 6 months

Patients will rate their perceptions of pain associated with surgery both pre-op and at 4 weeks and 6 months post-op.

次要结局

  • Change in general health related quality of life(Baseline, 4 weeks and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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