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

Completed
Conditions
Brain Fog
Registration Number
NCT05519774
Lead Sponsor
Inova Health Care Services
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of months to recruit4 months

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

Correlation between the TOSL score and PAOFI score6 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Inova HCS

🇺🇸

Falls Church, Virginia, United States

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