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

Recruiting

• Conditions: Breast Cancer Survivors
• Interventions: Other: Assessments; Other: Assessment (Survivors Only); Other: APOE and DNA Isolation

• Registration Number: NCT06334354
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-03-28
• Study Start: 2024-05-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 420

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer Survivor (BCS)	Assessments	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.
Breast Cancer Survivor (BCS)	Assessment (Survivors Only)	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)	APOE and DNA Isolation	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.
Breast Cancer Survivor (BCS)	APOE and DNA Isolation	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)	Assessments	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.

Primary Outcome Measures

Name	Time	Method
examine cognitive effects	within 45 days of participant consent	of remote cancer diagnosis and treatment and potential association with increased/accelerated deficit accumulation in older survivors.The primary outcome is cognitive performance, as measured by CogSuite aggregate intra-individual variability, the average intra-individual variability across the subtests. Cognition will be assessed using the CogSuite battery of five subtests: 1) Attention Network Test; 2) Mental Rotation; 3) Stop Signal Delay; 4) N-back; and 5) Psychomotor Speed measures.

Secondary Outcome Measures

Name	Time	Method
measure levels of smoking exposure	within 45 days of participant consent	by testing cotinine (an important metabolite of nicotine) in urine samples to examine possible interactions of smoking history with genetic variants, e.g., APOE ε4+, on cognition

Trial Locations

Locations (7)

Memorial Sloan Kettering Monmouth (All protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities); 🇺🇸 Uniondale, New York, United States