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Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning (ACT I)

Inova Health Care Services logo

Inova Health Care Services

Status

Completed

Conditions

Brain Fog

Study type

Observational

Funder types

Other

Identifiers

NCT05519774
U21-08-4519

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Ebtehal Al Shami; Adam Cohen, MD

Data sourced from clinicaltrials.gov

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