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

Recruiting now

Conditions studied: Breast Cancer Survivors

In brief

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.

Key facts

Study ID: NCT06334354
Run by: Memorial Sloan Kettering Cancer Center
People needed: 420
Starts: 2024-05-10
Expected to finish: 2028-08-31
Last updated by the study team: 2026-05-14

Who can join

Age: 60 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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:
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)
What is your preferred language for healthcare? (must respond English)

You may not qualify if…

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

Where it is running

Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (enrolling)
Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (enrolling)
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack, New York, United States (enrolling)
Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (enrolling)
Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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