Clinical trial NCT06334354: A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC)
Official title: Cognitive Aging in Older Long-term Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Survivors
Keywords: Cognitive aging
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 420
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors will be recruited in Breast Medicine Service clinics at the Breast and Imaging Center (BAIC) 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.

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.


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 65-80
* 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

Primary outcomes:
measure: examine cognitive effects
timeFrame: within 45 days of participant consent
Secondary outcomes:
measure: measure levels of smoking exposure
timeFrame: within 45 days of participant consent
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Root, PhD
role: PRINCIPAL_INVESTIGATOR
References: