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

Breast Cancer Survivors Clinical Trial

— TRAC  

Official title:

Cognitive Aging in Older Long-term Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334354
• Other study ID #: 23-320
• Status: Recruiting
• Start date: March 19, 2024
• Est. completion date: March 2029

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: James Root, PhD
• Phone: 646-888-0035
• Email: rootj[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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 1-3 breast cancer diagnosed between 55-60 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 with loss of consciousness for 30+ minutes or more
• 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, any history of cancer except non-melanoma skin cancer or breast cancer

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

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

Other:
• Assessments
Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment
• Assessment (Survivors Only)
*Tumor/Treatment Variables (Survivors Only)
• APOE and DNA Isolation
Biospecimens procurement and processing

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	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 Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 e4+, on cognition	within 45 days of participant consent

External Links

•   Memorial Sloan Kettering Cancer Center