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

NCT03619083 | Active Not Recruiting

• 1 other identifier: 18-240
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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

Keywords

Assessments; Sensory Gating; Attention; Executive Control; 18-240

Outcome Measures

Primary Outcomes (1)

• congnitive changes in patients

  using the Sensory-Attention-Executive Battery

  3 years

Study Arms (3)

Breast cancer patients treated with chemotherapy

Other: SAE battery; Behavioral: Assessments

patients not exposed to chemotherapy

Other: SAE battery; Behavioral: Assessments

healthy controls

Other: SAE battery; Behavioral: Assessments

Interventions

SAE battery OTHER

The SAE battery yields 12 variables.

Also known as: Sensory-Attention-Executive

Breast cancer patients treated with chemotherapy; healthy controls; patients not exposed to chemotherapy

Assessments 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.

Breast cancer patients treated with chemotherapy; healthy controls; patients not exposed to chemotherapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)\*\*

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• The City College of New York: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James Root, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 7, 2018
• Study Start: July 13, 2018
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)