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

NCT05519774 | Completed

• 1 other identifier: U21-08-4519
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Fog

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men or women with stage I-III breast cancer.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead
• The University of Texas at Dallas: collaborator

Study Sites (1)

Inova HCS

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Mental Fatigue; Breast Neoplasms

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Adam Cohen, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 29, 2022
• Study Start: August 1, 2022
• Primary Completion: June 18, 2024
• Study Completion: October 18, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

US (1)