Brain FogACT INCT05519774
Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning
An observational study of Brain Fog, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Fog
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 18 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men or women with stage I-III breast cancer.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Breast cancer
- Medical subject headings
- Mental Fatigue, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of months to recruit
Number of months between opening of recruitment and recruitment date of the 10th subject.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Aug 2022
- Primary completion18 Jun 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain FogStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas at Dallas
- Responsible party
- Sponsor
- Investigators
- Adam Cohen, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519774
- Sponsor's protocol ID
- U21-08-4519
- Acronym
- ACT I
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cancer Related Brain Fog Using the Test of Strategic Learning
- ClinicalTrials.gov ID
- NCT05519774
- Acronym / sponsor ID
- ACT I / U21-08-4519
- Conditions
- Brain Fog
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- The University of Texas at Dallas
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men or women with stage I-III breast cancer.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of months to recruit
Time frame: 4 months
Number of months between opening of recruitment and recruitment date of the 10th subject.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Cohen, MD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Fog, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of months to recruit (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.