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OpenTrials
Completed

NCT Number: NCT05519774

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova HCS

Falls Church, Virginia, 22042, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of months to recruit

    Time frame: 4 months

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

  2. Correlation between the TOSL score and PAOFI score

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • The University of Texas at Dallas

Registry information

Acronym: ACT I

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2022
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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