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临床试验/NCT05519774
NCT05519774已完成不适用

Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning

Inova Health Care Services1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年8月1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
54
试验地点
1
主要终点
Number of months to recruit

研究概览

简要总结

The Inova research team will ask people who have had an experience of breast cancer and related changes to their cognition to complete some scales that researchers have established describe brain fog (called patient reported outcomes) and compare those results to the TOSL results. This will be done twice to see if changes are detected similarly on both types of measures.

详细描述

Current brain fog research struggles to clearly define and measure brain fog because the changes are more subtle than typically show up on "objective" tests. These subtle changes on the tests, may not appear subtle in everyday life. This disconnect can lead to people managing cancer feeling unheard or unbelieved about their experience with brain fog. However, cognitive research outside of the cancer population has developed and tested tests that are more sensitive to cognitive changes and improvements. The goal of this initial research project is to test a more sensitive test, called the Test of Strategic Learning (TOSL), to see if it is sensitive enough to objectively measure brain fog.

One other problem with previous brain fog research is that it has not included a diverse population. Therefore, what we think we know about brain fog may not be true for everyone with brain fog. The diverse population in the DMV area that Inova serves deserves to have their experiences represented in the research.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • 18 years of age or older
  • ECOG performance status ≤ 2
  • Patients diagnosed or with a history of breast cancer within the last 5 years.
  • Life expectancy of at least 3 months
  • Subject reports experiencing brain fog or cognitive impairment that the subject attributes to cancer or cancer therapy
  • Able to sit for one hour and attend and respond to verbal and written instructions.
  • Able to use a computer

排除标准

  • Brain metastases from breast cancer
  • Severe hearing or visual impairment
  • Unable to give informed consent
  • Unable to read and write in English
  • Those diagnosed with history of neurologic injuries or disorders (e.g. seizures, strokes, traumatic brain injury, brain surgery, neurodegenerative disorders) other than those attributable to cancer or cancer therapy.

结局指标

主要结局

Number of months to recruit

时间窗: 4 months

Number of months between opening of recruitment and recruitment date of the 10th subject.

Correlation between the TOSL score and PAOFI score

时间窗: 6 months

Spearman correlation coefficient between the TOSL Lessons score and the PAOFI higher level cognition subscale score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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