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

Cognitive Aging in Older Long-term Breast Cancer Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Other: Assessments; Other: Assessment (Survivors Only); Other: APOE and DNA Isolation

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: James Root, PhD; Phone Number: 646-888-0035; Email: rootj@mskcc.org
• Study Contact Backup: Name: Denise Correa, PhD; Phone Number: 212-610-0491

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (All Protocol Activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (All Protocol Activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Principal Investigator: James Root, PhD
      • Contact: James Root, PhD; Phone Number: 646-888-0035
      • Contact: Denise Correa, PhD; Phone Number: 212-610-0491
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (All protocol activities)
      • Contact: James Root, PhD; Phone Number: 646-888-0035

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Assessments; Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment; Other: Assessment (Survivors Only); *Tumor/Treatment Variables (Survivors Only); Other: APOE and DNA Isolation; Biospecimens procurement and processing
Non-cancer Control (NCC); 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.	Other: Assessments; Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment; Other: APOE and DNA Isolation; Biospecimens procurement and processing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
examine cognitive effects	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.	within 45 days of participant consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure levels of smoking exposure	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	within 45 days of participant consent

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: James Root, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive aging
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Investigative Techniques; Therapeutics; Lipids; Behavior Control; Immobilization; Apolipoproteins; Lipoproteins; Apoproteins; Restraint, Physical; Apolipoproteins E
• Other Study ID Numbers: 23-320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No