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

March 9, 2026 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: James Root, PhD
  • Phone Number: 646-888-0035

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 300 participants (n = 100 breast cancer patients treated with chemotherapy, n = 100 breast cancer patients without chemotherapy treatment, n = 100 matched controls).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy controls
Other: SAE battery
The SAE battery yields 12 variables.
Other Names:
  • Sensory-Attention-Executive
Behavioral: 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.
Breast cancer patients treated with chemotherapy
Other: SAE battery
The SAE battery yields 12 variables.
Other Names:
  • Sensory-Attention-Executive
Behavioral: 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.
patients not exposed to chemotherapy
Other: SAE battery
The SAE battery yields 12 variables.
Other Names:
  • Sensory-Attention-Executive
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
congnitive changes in patients
Time Frame: 3 years
using the Sensory-Attention-Executive Battery
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The City College of New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Root, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings