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

Terminated

• Conditions: Breast Cancer
• Interventions: Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

• Registration Number: NCT01473680
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who will receive chemo	EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire	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.
Patients who will not receive chemo	EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire	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.
Healthy Controls	EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
neuropsychologic (NP) features	2 years	through administration of NP and psychological instruments and EEG

Secondary Outcome Measures

Name	Time	Method
electrophysiologic features	2 years	through administration of NP and psychological instruments and EEG

Trial Locations

Locations (4)

Lincoln Hospital; 🇺🇸 Bronx, New York, United States

The City College of New York; 🇺🇸 New York, New York, United States

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