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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • 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

• Ages Eligible for Study: 18 years to 61 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinic, The Ralph Lauren Center for Cancer Care and Prevention (RLCCCP)located in Harlem and Lincoln Hospital located in the Bronx.

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

3

Cohorts and Interventions

Group / Cohort	Intervention / 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.	Other: EEG, 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.
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.	Other: EEG, 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.
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.	Other: EEG, 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: The City College of New York; Ralph Lauren Center for Cancer Care and Prevention; Lincoln Medical and Mental Health Center
• Investigators: Principal Investigator: Elizabeth Ryan, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 12, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Evaluation; EEG; Questionnaires; minority breast cancer patients; 11-139
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 11-139