Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619083
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
The City College of New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Other: SAE battery Behavioral: Assessments

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Sensory Gating, Attention, and Executive Control in Breast Cancer
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Breast cancer patients treated with chemotherapy Other: SAE battery
The SAE battery yields 12 variables.
Other Name: 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 Name: 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.

healthy controls Other: SAE battery
The SAE battery yields 12 variables.
Other Name: 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.




Primary Outcome Measures :
  1. congnitive changes in patients [ Time Frame: 3 years ]
    using the Sensory-Attention-Executive Battery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
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).
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619083


Contacts
Layout table for location contacts
Contact: Tim Alhes, PhD 646-888-0048 ahlest@mskcc.org
Contact: James Root, PhD 646-888-0035

Locations
Layout table for location information
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Tim Ahles, PhD    646-888-0048      
Contact: James Root, PhD    646-888-0035      
Principal Investigator: Tim Ahles, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
The City College of New York
Investigators
Layout table for investigator information
Principal Investigator: Tim Alhes, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03619083    
Other Study ID Numbers: 18-240
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Assessments
Sensory Gating
Attention
Executive Control
18-240
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases