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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01473680
Enrollment
2
Registered
2011-11-17
Start date
2011-11-30
Completion date
2012-09-30
Last updated
2012-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

minority breast cancer patients, EEG, Evaluation, Questionnaires, 11-139

Brief summary

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.

Interventions

OTHEREEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

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.

Sponsors

The City College of New York
CollaboratorOTHER
Ralph Lauren Center for Cancer Care and Prevention
CollaboratorOTHER
Lincoln Medical and Mental Health Center
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 61 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
neuropsychologic (NP) features2 yearsthrough administration of NP and psychological instruments and EEG

Secondary

MeasureTime frameDescription
electrophysiologic features2 yearsthrough administration of NP and psychological instruments and EEG

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026