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
1 other identifier
observational
420
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
May 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
March 23, 2026
March 1, 2026
4.3 years
March 19, 2024
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
measure levels of smoking exposure
within 45 days of participant consent
Study Arms (2)
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.
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.
Interventions
Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment
\*Tumor/Treatment Variables (Survivors Only)
Biospecimens procurement and processing
Eligibility Criteria
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.
You may qualify if:
- 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)
You may not qualify if:
- 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, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
Biospecimen
Salvia, Urine
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Root, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2024
First Posted
March 28, 2024
Study Start
May 10, 2024
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.