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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Fog

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Adam Cohen, MD; Phone Number: 571-472-1380; Email: neuro-oncology@inova.org
• Study Contact Backup: Name: Ebtehal Al Shami; Email: neuro-oncology@inova.org

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova HCS
      • Contact: Ebtehal Al Shami; Email: neuro-oncology@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Men or women with stage I-III breast cancer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of months to recruit	Number of months between opening of recruitment and recruitment date of the 10th subject.	4 months
Correlation between the TOSL score and PAOFI score	Spearman correlation coefficient between the TOSL Lessons score and the PAOFI higher level cognition subscale score.	6 months

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: The University of Texas at Dallas
• Investigators: Principal Investigator: Adam Cohen, MD, Inova Health Care Services

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Fatigue; Mental Fatigue
• Other Study ID Numbers: U21-08-4519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No