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

NCT ID: NCT05519774

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-10-18

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.

Conditions

Brain Fog

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Inova Health Care Services

Locations

Inova HCS

Falls Church, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U21-08-4519

Identifier Type: -

Identifier Source: org_study_id