Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States
- Lincoln Hospital
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States
- Ralph Lauren Center for Cancer Care and Prevention
-
New York, New York, United States
- The City College of New York
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Patients who will receive chemo
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.
|
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.
|
|
Patients who will not receive chemo
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.
|
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.
|
|
Healthy Controls
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neuropsychologic (NP) features
Time Frame: 2 years
|
through administration of NP and psychological instruments and EEG
|
2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
electrophysiologic features
Time Frame: 2 years
|
through administration of NP and psychological instruments and EEG
|
2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Elizabeth Ryan, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
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
- 11-139
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