Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients |
- neuropsychologic (NP) features [ Time Frame: 2 years ] [ Designated as safety issue: No ]through administration of NP and psychological instruments and EEG
- electrophysiologic features [ Time Frame: 2 years ] [ Designated as safety issue: No ]through administration of NP and psychological instruments and EEG
| Enrollment: | 2 |
| Study Start Date: | November 2011 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 61 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
MSKCC clinic, The Ralph Lauren Center for Cancer Care and Prevention (RLCCCP)located in Harlem and Lincoln Hospital located in the Bronx.
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.
Contacts and Locations| United States, New York | |
| Lincoln Hospital | |
| Bronx, New York, United States | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Ralph Lauren Center for Cancer Care and Prevention | |
| New York, New York, United States | |
| The City College of New York | |
| New York, New York, United States | |
| Principal Investigator: | Elizabeth Ryan, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01473680 History of Changes |
| Other Study ID Numbers: | 11-139 |
| Study First Received: | November 10, 2011 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
minority breast cancer patients EEG Evaluation Questionnaires 11-139 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013