Recruiting NCT06334354

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

— Observational Breast Cancer Survivors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Assessments, Assessment (Survivors Only), APOE and DNA Isolation.
Who it may be relevant to: Registry conditions: Breast Cancer Survivors. Basic parameters: 60 years — 80 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cognitive Aging in Older Long-term Breast Cancer Survivors

Overview

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.

Interventions

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

Primary outcome measures

examine cognitive effects [Time frame: within 45 days of participant consent]

Secondary outcome measures (1)

measure levels of smoking exposure [Time frame: within 45 days of participant consent]

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Case-control

Study locations

United States · 7 centers

Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
Memorial Sloan Kettering Cancer Center — New York
Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Identifiers

NCT: NCT06334354 · 23-320

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗