A Study of Attention and Memory Processes in Breast Cancer Survivors
Neural and Cognitive Mechanisms of Attention and Memory Deficits in Cancer Survivors
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: James Root, PhD
- Phone Number: 646-888-0035
- Email: rootj@mskcc.org
Study Contact Backup
- Name: Tim Alhes, PhD
- Phone Number: 646-888-0048
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For All Paricipants:
- As per medical record or self-report, female
- As per medical record or self-report, age 50-70
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- English fluent (as per self reported fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff/preference of English language for healthcare)**
- 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
For Survivors:
- As per medical record or self-report, AJCC stages 0-3 breast cancer
- As per medical record or self-report, at least 1-year post-treatment for breast cancer (including surgery, and chemotherapy, with or without radiation
- As per medical record or self-report, current endocrine therapy
For Healthy Controls:
- As per 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
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, participation in a conflicting research study (i.e. another neurocognitive study utilizing HVLT and BVMT tasks.)
For Survivors 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
- As per medical record or self-report, disease recurrence.
For Healthy Controls only:
- As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
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Breast cancer survivors
Breast cancer survivors ages 50-70 with AJCC stages 0-3 breast cancer who are at least 1 year post-treatment (including surgery, radiation, and chemotherapy, with or without current endocrine therapy)
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Healthy controls
Healthy controls ages 50-70 with no history of cancer.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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test early attentional deficits
Time Frame: baseline
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Using EEG measures of brain activity during a cognitive-experimental long-term memory task to evaluate the mechanisms underlying attention, initial learning, retrieval, and metamemory performance.
P3 amplitude as measured by EEG at the Pz electrode.
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baseline
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abnormal event-related potential (ERP) during initial learning
Time Frame: baseline
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During passive tasks (such as a paired-click paradigm)The proposed paradigm is adapted from previous work using EEG to measure the relationship between attention, learning, and subsequent performance on a verbal long-term memory task in healthy adults41.
Relative to standard neuropsychological measures, this technique provides a more finely grained approach to investigating the effect of attentional mechanisms on subcomponents of initial learning and retrieval processes in long-term memory.
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baseline
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: James Root, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 21-161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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