Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients

Study Overview
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Brief Summary
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This study is being done to find out if it is possible to enroll minority women with breast cancer in a study of how chemotherapy may affect their ability to answer certain questions and perform certain tasks that measure brain activity. The investigators want to look at thinking and brain activity in patients to see if cancer treatments can cause any brain changes. For this study, women without cancer, are being asked to participate in order to compare the answers to the questions and the brain wave activity measured in the women with cancer to women who don't have cancer.

Official Title
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Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
* Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
* Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years old, but not older than 61 years old; Is female; Is Hispanic of any race or Black/African American Is fluent in English (see explanation in Section 7.0 Assessment / Evaluation Plan - Language Determination); Has a diagnosis of breast cancer (Stage I-III); Is treatment naïve and scheduled to receive chemotherapy, radiation, or endocrine therapy. Healthy Control Subject Inclusion Criteria Is at least 18 years old, but not older than 61 years old; Is female; Is Hispanic or Black Non-Hispanic; Is fluent in English Exclusion Criteria: Participants with neurologic illnesses affecting cognition, (i.e., Traumatic Brain Injury with a loss of consciousness >30 min., etc.) or severe psychiatric illness (i.e., schizophrenia, bipolar disorder, etc.); A hearing or visual deficit that impairs the ability to participate in the EEG tasks. Any condition which prevents application of the 160 EEG electrodes spaced evenly across the participant's scalp, which includes dreadlocks, and hair extensions applied by weaving, braiding, gluing, or clips-. unless the participants are willing to undo these styles prior to the EEG. Mini-Mental State Exam (MMSE) <16 (telephone version); MMSE <20 (in-person version) Prior chemotherapy for any malignancy Regularly taking opiates or take a daily, morning benzodiazepine or have taken a prn benzodiazepine prior to the assessment. Healthy Control Subject Exclusion Criteria Current or historical cancer diagnosis (a previous diagnosis of basal cell skin carcinoma is allowable) History of neurologic illnesses affecting cognition, (i.e., Traumatic Brain Injury with a loss of consciousness >30 min., etc.) or severe psychiatric illness (i.e., schizophrenia, bipolar disorder, etc.); A hearing or visual deficit that impairs the ability to participate in the EEG tasks. Any condition which prevents application of the 160 EEG electrodes spaced evenly across the participant's scalp, which includes dreadlocks, and hair extensions applied by weaving, braiding, gluing, or clips-. unless the participants are willing to undo these styles prior to the EEG Mini-Mental State Exam (MMSE) <16 (telephone version); MMSE <20 (in-person version) Regularly taking opiates or takes a daily, morning benzodiazepine or has taken a prn benzodiazepine prior to the assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who will receive chemo<br>This study is an assessment of individuals' cognitive functioning through administration of NP and psychological instruments and EEG. These assessments do not require manipulation of a participant's environment to elicit change in behavior or treatment outcome. NP and psychological instruments. | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire<br>* Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.<br>|
| Patients who will not receive chemo<br>This study is an assessment of individuals' cognitive functioning through administration of NP and psychological instruments and EEG. These assessments do not require manipulation of a participant's environment to elicit change in behavior or treatment outcome. NP and psychological instruments. | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire<br>* Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.<br>|
| Healthy Controls<br>This study is an assessment of individuals' cognitive functioning through administration of NP and psychological instruments and EEG. These assessments do not require manipulation of a participant's environment to elicit change in behavior or treatment outcome. NP and psychological instruments. | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire<br>* Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropsychologic (NP) features | through administration of NP and psychological instruments and EEG | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrophysiologic features | through administration of NP and psychological instruments and EEG | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, minority breast cancer patients, Evaluation, Questionnaires, 11-139