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NCT Number: NCT06334354

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

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.

Recruiting

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Key information

Age range

60 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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)

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

Treatment and study plan

Assessments

Other

Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment

Assessment (Survivors Only)

Other

*Tumor/Treatment Variables (Survivors Only)

APOE and DNA Isolation

Other

Biospecimens procurement and processing

Primary outcomes

  1. examine cognitive effects

    Time frame: 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 outcomes

  1. measure levels of smoking exposure

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Correa, PhD

CONTACT

212-610-0491

James Root, PhD

CONTACT

[email protected]

646-888-0035

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Cognitive Aging in Older Long-term Breast Cancer Survivors

Acronym: TRAC

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 28, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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