Assessment of Sensory Gating, Attention, and Executive Control in Breast Cancer

NCT ID: NCT03619083

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 187 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2026-07-31

Brief Summary

This study is being done to find out if a new series of evaluations called the SAE (Sensory-Attention-Executive) Battery can help researchers learn more about how cancer treatment does or does not change the way the brain processes/filters information, emotions, attention span, and behavior by comparing the results of the SAE Battery with traditional evaluations like questionnaires.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast cancer patients treated with chemotherapy

SAE battery

Intervention Type: OTHER

The SAE battery yields 12 variables.

Assessments

Intervention Type: BEHAVIORAL

Assessments of their neurocognitive performance will be assessed longitudinally, at 4 time points: prior to adjuvant treatment (post-surgery); 1 month (with a +4 week window) post-chemotherapy; and again at the 12 and 24 months (with a +4 week window) post-treatment time points. These assessment time points are denoted as T1 though T4, respectively. The assessment schedule for the HC and CT- groups will be yoked against that of the CT+ cohort.

patients not exposed to chemotherapy

SAE battery

Intervention Type: OTHER

The SAE battery yields 12 variables.

Assessments

Intervention Type: BEHAVIORAL

Assessments of their neurocognitive performance will be assessed longitudinally, at 4 time points: prior to adjuvant treatment (post-surgery); 1 month (with a +4 week window) post-chemotherapy; and again at the 12 and 24 months (with a +4 week window) post-treatment time points. These assessment time points are denoted as T1 though T4, respectively. The assessment schedule for the HC and CT- groups will be yoked against that of the CT+ cohort.

healthy controls

SAE battery

Intervention Type: OTHER

The SAE battery yields 12 variables.

Assessments

Intervention Type: BEHAVIORAL

Assessments of their neurocognitive performance will be assessed longitudinally, at 4 time points: prior to adjuvant treatment (post-surgery); 1 month (with a +4 week window) post-chemotherapy; and again at the 12 and 24 months (with a +4 week window) post-treatment time points. These assessment time points are denoted as T1 though T4, respectively. The assessment schedule for the HC and CT- groups will be yoked against that of the CT+ cohort.

Interventions

SAE battery

The SAE battery yields 12 variables.

Intervention Type: OTHER

Assessments

Assessments of their neurocognitive performance will be assessed longitudinally, at 4 time points: prior to adjuvant treatment (post-surgery); 1 month (with a +4 week window) post-chemotherapy; and again at the 12 and 24 months (with a +4 week window) post-treatment time points. These assessment time points are denoted as T1 though T4, respectively. The assessment schedule for the HC and CT- groups will be yoked against that of the CT+ cohort.

Intervention Type: BEHAVIORAL

Other Intervention Names

Sensory-Attention-Executive

Eligibility Criteria

Inclusion Criteria

For Patients:

• As per medical record or self-report, female
• As per medical record or self-report, age 40-75 at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
• As per medical record or self-report, AJCC stages 0-3 breast cancer
• As per medical record or self-report, post-surgery for current breast cancer diagnosis (surgery includes cryosurgery/cryotherapy)
• Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
• As per medical record or self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants and anxiolytics) on a daily basis, 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)**

For Healthy Controls:

• As per medical record or self-report, female
• As per medical record or self-report, age 40-75
• 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.
• As per self report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery
• Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
• 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)**

Exclusion Criteria

For 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 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 aides)
• 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, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors

For Patients only:

• As per medical record or self-report, history of another type of cancer or prior breast cancer diagnosis except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma and, at the discretion of the PI, early stage secondary cancer diagnoses treated only with surgery
• As per medical record or self-report, disease recurrence. ** Language verification: For both patients and controls, prior to enrollment, all will be asked the following two questions by an RSA 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The City College of New York

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Root, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

18-240

Identifier Type: -

Identifier Source: org_study_id