Status:
TERMINATED
Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
The City College of New York
Ralph Lauren Center for Cancer Care and Prevention
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-61 years
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 certa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01473680
Start Date
November 1 2011
End Date
September 1 2012
Last Update
September 13 2012
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
2
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
3
The City College of New York
New York, New York, United States
4
Lincoln Hospital
The Bronx, New York, United States