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


N/A
18 Years
61 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

neuropsychologic (NP) features

Outcome Description:

through administration of NP and psychological instruments and EEG

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Elizabeth Ryan, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-139

NCT ID:

NCT01473680

Start Date:

November 2011

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • minority breast cancer patients
  • EEG
  • Evaluation
  • Questionnaires
  • 11-139
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Ralph Lauren Center for Cancer Care and Prevention New York, New York  10035
Lincoln Hospital Bronx, New York  10451
The City College of New York New York, New York