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

This study has been terminated.
Sponsor:
Collaborators:
The City College of New York
Ralph Lauren Center for Cancer Care and Prevention
Lincoln Medical and Mental Health Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01473680
First received: November 10, 2011
Last updated: September 12, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • neuropsychologic (NP) features [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    through administration of NP and psychological instruments and EEG


Secondary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473680

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
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
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
  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 July 22, 2014