Clinical trial NCT01473680: Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
Official title: Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: minority breast cancer patients
EEG
Evaluation
Questionnaires
11-139
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The City College of New York
name: Ralph Lauren Center for Cancer Care and Prevention
name: Lincoln Medical and Mental Health Center
First posted: 2011-11-17
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: neuropsychologic (NP) features
timeFrame: 2 years
Secondary outcomes:
measure: electrophysiologic features
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Ralph Lauren Center for Cancer Care and Prevention
state: New York
city: New York
country: United States
facility: The City College of New York
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Elizabeth Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: