Breast Cancer SurvivorsNCT03674437
Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
An observational study of Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to measure changes in cognitive (mental) function in cancer survivors using a brief, reliable, game-like set of tests that can be completed outside the clinic, as an alternative to traditional neurocognitive assessments. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Traditional Neurocognitive Assessments and Online Cognitive Battery (Cogsuite)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 441 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: MSK patients will be recruited through the survivorship clinics after having been identified via a Dataline query and/or weekly clinic schedules or through direct referrals from a member of the patient"s treatment team.
Who may be able to join
- For All Participants:
- As per medical record or self-report,Female
- As per medical record or self-report,Age 40-65 at time of assessment
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- As per self-report, If currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics), on a daily basis dose must have been stable for at least two months prior to enrollment.
- English fluent (as per self-reported fluency of "very well") Language verification: For both patients and controls, prior to enrollment, all will be asked the following two questions by an CRC to verify English fluency necessary for participation in the study:
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- How well do you speak English? (must respond "Very well" when given the choices of Very well, Well, Not well, Not at all, Don"t know, or Refused)
- What is your preferred language for healthcare? (must respond English)
- For Patients:
- As per medical record or self-report, female
- As per medical record or self-report, age 40-65 at time of assessment
- As per medical record or self-report, history of AJCC stages 0-3 breast cancer
- As per medical record or self-report, greater than six months post-treatment and within 10 years of treatment completion (Note: "post-treatment" refers to completion of surgery, radiation, and/or chemotherapy; a patient who is post-treatment but is on endocrine therapy is still eligible to participate.)
- For Healthy Controls:
- As per medical record or self-report, female
- As per medical record or self-report, age 40-65 at time of assessment
- As per self-report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma, and at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)
- For Healthy 21-25 year old Group:
- As per medical record or self-report, age 21-25 at time of assessment
- As per self-report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma, and at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)
Who cannot join
- For All Participants:
- As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer"s disease, Parkinson"s disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).
- As per medical record or self-report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.
- As per self-report, fine motor/motor impairments that interfere with participant"s ability to use a keyboard.
- As per medical record or self-report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
- As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
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- As per self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxan) for rheumatoid arthritis, psoriasis or Crohn"s disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
- For Patients only:
- As per medical record or self-report, history of another type of cancer, except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery (for example, endometrial or cervical cancer)
- For all remote administrations:
- Minimum Hardware/Software Requirements*:
- Processor: Intel Core i3 Processer or greater
- Memory: 4GB RAM or greater
- Operating System: Recent version of Windows or OS X
- Browser: Google Chrome version 64 or higher
- Internet Speed: 1.5 Mbps recommended
- As per self-report, a quiet space (home or office, door closed) to complete the assessments
- Enformia Cognition will provide a web URL (https://www.cogsuite.com/testme) that participants can use to check if they have the minimum requirements. The URL will clearly state if the user has adequate hardware using green and red text and symbols. The test URL will also return a short 5 sequence numeric validation code (xx-xxx) for each browser checked. The validation code will allow Enformia to lookup the specific hardware that was tested. Research Associates can direct prospects to the test web URL during their phone screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to measure changes in cognitive (mental) function in cancer survivors using a brief, reliable, game-like set of tests that can be completed outside the clinic, as an alternative to traditional neurocognitive assessments. This set of computerized tests, the Cogsuite Assessment, is expected to improve our ability to identify cognitive impairments in people who have been treated for cancer, so that we can (1) learn more about which cognitive functions are affected by cancer treatment, and (2) guide that treatment more effectively.
- Conditions
- Breast Cancer Survivors
- Being tested
- Traditional Neurocognitive Assessments, Online Cognitive Battery (Cogsuite)
- Keywords
- Quality of Life, Cognitive Function, 18-294
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Neurocognitive AssessmentsBehavioural
Traditional Neurocognitive Assessments given with pen and paper
Online Cognitive Battery (Cogsuite)Behavioural
Cognition (Cogsuite) for a battery that consists of seven measurements.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions. Receives: Behavioral: Traditional Neurocognitive Assessments; Behavioral: Online Cognitive Battery (Cogsuite) | |
| Healthy Controls | Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions. Receives: Behavioral: Traditional Neurocognitive Assessments; Behavioral: Online Cognitive Battery (Cogsuite) | |
| Healthy 21-25 year olds | Healthy participants between the ages of 21 and 25 will be administered the Cogsuite Battery remotely. These participants will not be matched to any other groups and will not be asked for their full medical histories. They will only complete the assessment only once. Receives: Behavioral: Traditional Neurocognitive Assessments; Behavioral: Online Cognitive Battery (Cogsuite) |
What is being measured
The primary outcome is the main question the study is designed to answer.
validate computerized cognitive measures (Cogsuite Battery)
These will include 14 correlations, across the two cohorts and 7 tests (Modified Attention Network Test, N-Back Test, Stop-signal Test, Mental Rotation Test, Verbal Fluency Test, Motor Function Test, and Processing Speed Test).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start11 Sep 2018
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Susan Love Research Foundation, ENFORMIA INC.
- Responsible party
- Sponsor
- Investigators
- James Root, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674437
- Sponsor's protocol ID
- 18-294
- Status last verified
- Nov 2026
- First submitted
- 12 Sep 2018
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online, Remote Cognitive Battery for Use in Cancer Survivorship
- ClinicalTrials.gov ID
- NCT03674437
- Acronym / sponsor ID
- 18-294
- Conditions
- Breast Cancer Survivors
- Keywords
- Quality of Life, Cognitive Function, 18-294
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Dr. Susan Love Research Foundation, ENFORMIA INC.
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Sep 2018 (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 purpose of this study is to measure changes in cognitive (mental) function in cancer survivors using a brief, reliable, game-like set of tests that can be completed outside the clinic, as an alternative to traditional neurocognitive assessments. This set of computerized tests, the Cogsuite Assessment, is expected to improve our ability to identify cognitive impairments in people who have been treated for cancer, so that we can (1) learn more about which cognitive functions are affected by cancer treatment, and (2) guide that treatment more effectively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | – | Behavioral: Traditional Neurocognitive Assessments, Behavioral: Online Cognitive Battery (Cogsuite)Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions. |
| Healthy Controls | – | Behavioral: Traditional Neurocognitive Assessments, Behavioral: Online Cognitive Battery (Cogsuite)Each main cohort has 2 sub-groups: One sub-group in each main cohort will complete the traditional neurocognitive assessments and the Cogsuite Assessment at the MSK Counseling Center, and the other sub-group will complete the Cogsuite Assessment off-site, on their own computers, in a quiet space that is free of distractions. |
| Healthy 21-25 year olds | – | Behavioral: Traditional Neurocognitive Assessments, Behavioral: Online Cognitive Battery (Cogsuite)Healthy participants between the ages of 21 and 25 will be administered the Cogsuite Battery remotely. These participants will not be matched to any other groups and will not be asked for their full medical histories. They will only complete the assessment only once. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MSK patients will be recruited through the survivorship clinics after having been identified via a Dataline query and/or weekly clinic schedules or through direct referrals from a member of the patient"s treatment team.
Key inclusion criteria (20 listed)
- As per medical record or self-report,Female
- As per medical record or self-report,Age 40-65 at time of assessment
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- As per self-report, If currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics), on a daily basis dose must have been stable for at least two months prior to enrollment.
- English fluent (as per self-reported fluency of "very well") Language verification: For both patients and controls, prior to enrollment, all will be asked the following two questions by an CRC to verify English fluency necessary for participation in the study:
Key exclusion criteria (18 listed)
- As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer"s disease, Parkinson"s disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).
- As per medical record or self-report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.
- As per self-report, fine motor/motor impairments that interfere with participant"s ability to use a keyboard.
- As per medical record or self-report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
- As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Neurocognitive AssessmentsTraditional Neurocognitive Assessments given with pen and paper | Behavioural | Breast Cancer Survivors, Healthy 21-25 year olds, Healthy Controls |
| Online Cognitive Battery (Cogsuite)Cognition (Cogsuite) for a battery that consists of seven measurements. | Behavioural | Breast Cancer Survivors, Healthy 21-25 year olds, Healthy Controls |
Primary outcome
validate computerized cognitive measures (Cogsuite Battery)
Time frame: 2 years
These will include 14 correlations, across the two cohorts and 7 tests (Modified Attention Network Test, N-Back Test, Stop-signal Test, Mental Rotation Test, Verbal Fluency Test, Motor Function Test, and Processing Speed Test).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
James Root, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center 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 20 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
validate computerized cognitive measures (Cogsuite Battery) (time frame: 2 years). 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 3 Nov 2026.