Recruiting

Observational StudyA Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC)

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06334354

Conditions

Breast Cancer Survivors

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Assessments

Assessment (Survivors Only)

APOE and DNA Isolation

Study Details

Brief summary:

The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants.

Conditions

Breast Cancer Survivors

Study ID

NCT06334354

Start date

May 10, 2024

Status verified date

May, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

All Participants:

Per medical record and/or self-report, identifies as female
Per medical record and/or self-report, currently age 60-80
Per self-report, has access to a computer and internet connectivity
Score of <11 on Blessed Orientation-Memory-Concentration Test (BOMC)
As per medical record or self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment.
English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)\*\*

Breast Cancer Survivors:

Per medical record and/or self-report, history of stage 0-3 breast cancer diagnosed between 50-60 years of age
Per medical record and/or self-report, no evidence of disease (NED)

Non-Cancer Controls:

Per self-report, no history of breast cancer

Language verification: For both survivors and controls, prior to enrollment, all will be asked the following two questions by a CRC to verify English fluency necessary for participation in the study:

1. How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English)

Exclusion Criteria:

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 medical record or self-report, a diagnosis of a major Axis I psychiatric disorder including 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)
As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for lupus.
As per medical record or self-report, participation in a conflicting (overlapping neurocognitive assessments) research study (i.e. MSK 18-294)

Breast Cancer Survivors:

As per medical record or self-report, history of cancer recurrence
As per medical record or self-report, any history of another cancer except nonmelanoma skin cancer or first breast cancer (a secondary breast cancer is exclusionary)
As per medical record or self-report, breast cancer only treated with surgery

Non-Cancer Controls:

As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
As per medical record or self-report, any history of cancer except non-melanoma skin cancer

Study Design

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

Breast Cancer Survivor (BCS)

Enrolled participants will be asked to complete a one-time, remote neurocognitive assessment. The neurocognitive assessment will consist of the CogSuite Neurocognitive Battery, an online, remotely deliverable battery of cognitive experimental measures, and a standard battery of remote neuropsychological measures. DNA will be collected via mailed saliva kits to assess Apolipoprotein E (APOE) status.

Non-cancer Control (NCC)

Interventions

Assessments

Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment

Assessment (Survivors Only)

\*Tumor/Treatment Variables (Survivors Only)

APOE and DNA Isolation

Biospecimens procurement and processing

Primary outcome measure

examine cognitive effects [ Time Frame: within 45 days of participant consent ]

Central Contacts and Locations

Central contacts

James Root, PhD

646-888-0035 rootj@mskcc.org

Denise Correa, PhD

212-610-0491

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

James Root, PhD

646-888-0035

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

James Root, PhD

646-888-0035

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

James Root, PhD

646-888-0035

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

James Root, PhD

646-888-0035

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

James Root, PhD

646-888-0035

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

James Root, PhD

646-888-0035

Denise Correa, PhD

212-610-0491

Principal Investigator:

James Root, PhD

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

James Root, PhD

646-888-0035

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

Cognitive aging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-14.