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

NCT ID: NCT01473680

Last Updated: 2012-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-09-30

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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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minority breast cancer patients EEG Evaluation Questionnaires 11-139

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

Intervention Type OTHER

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.

EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

Intervention Type OTHER

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.

EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

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.


* 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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

61 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The City College of New York

OTHER

Sponsor Role collaborator

Ralph Lauren Center for Cancer Care and Prevention

OTHER

Sponsor Role collaborator

Lincoln Medical and Mental Health Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Site Status

The City College of New York

New York, New York, United States

Site Status

Lincoln Hospital

The Bronx, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan-Kettering Cancer Center

Other Identifiers

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11-139

Identifier Type: -

Identifier Source: org_study_id