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Trial Title:
Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning
NCT ID:
NCT05519774
Condition:
Brain Fog
Conditions: Official terms:
Mental Fatigue
Conditions: Keywords:
Breast cancer
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Men or women with stage I-III breast cancer.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Inova HCS
Address:
City:
Falls Church
Zip:
22042
Country:
United States
Start date:
August 1, 2022
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Inova Health Care Services
Agency class:
Other
Collaborator:
Agency:
The University of Texas at Dallas
Agency class:
Other
Source:
Inova Health Care Services
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519774
