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

NCT01473680 | Terminated

• 1 other identifier: 11-139
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• neuropsychologic (NP) features

  through administration of NP and psychological instruments and EEG

  2 years

Secondary Outcomes (1)

• electrophysiologic features

  2 years

Study Arms (3)

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

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

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

Interventions

EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire 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 receive chemo

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• The City College of New York: collaborator
• Ralph Lauren Center for Cancer Care and Prevention: collaborator
• Lincoln Medical and Mental Health Center: collaborator

Study Sites (4)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Location

The City College of New York

New York, New York, United States

Location

Lincoln Hospital

The Bronx, New York, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elizabeth Ryan, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 17, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

US (4)