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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called TRAC, is studying how thinking and memory skills change over time in women who have survived breast cancer, compared to women who have never had cancer and are the same age. The researchers will conduct tests to see how well participants can remember things, pay attention, and process information. This study aims to understand whether cancer treatment or the aging process affects these mental functions differently in breast cancer survivors.

To be part of this study, participants must be women aged 65 to 80, with breast cancer survivors needing to have been diagnosed with early-stage breast cancer (stages 1-3) and currently have no signs of the disease. Participants should also have stable medication for at least two months and be fluent in English. Those who have a history of certain neurological or psychiatric disorders, significant visual or hearing impairments, or other specific health conditions are not eligible. Participants can expect to complete cognitive tests and contribute to important research that may help improve understanding of cognitive health in cancer survivors.

Gender

FEMALE

Eligibility criteria

• 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