Breast CancerNCT01473680
Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 61 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
- How many people
- 2 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 61 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: MSKCC clinic, The Ralph Lauren Center for Cancer Care and Prevention (RLCCCP)located in Harlem and Lincoln Hospital located in the Bronx.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Ralph Lauren Center for Cancer Care and Prevention
New York, New York
The City College of New York
New York, New York
Lincoln Hospital
The Bronx, New York
About this study
Official title: Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
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.
- Conditions
- Breast Cancer
- Being tested
- EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire
- Keywords
- minority breast cancer patients, EEG, Evaluation, Questionnaires, 11-139
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireOther
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.
EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireOther
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.
EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire | |
| 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. Receives: Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire | |
| 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. Receives: Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychologic (NP) features
through administration of NP and psychological instruments and EEG
Measured: 2 years
Secondary outcomes (1)
electrophysiologic features
through administration of NP and psychological instruments and EEG
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York, Ralph Lauren Center for Cancer Care and Prevention, Lincoln Medical and Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ryan, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473680
- Sponsor's protocol ID
- 11-139
- Status last verified
- Sep 2012
- First submitted
- 10 Nov 2011
- Last updated
- 13 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Neuropsychologic and Electrophysiological Features of Cancer-Related Cognitive Side Effects in Racial and Ethnic Minority Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01473680
- Acronym / sponsor ID
- 11-139
- Conditions
- Breast Cancer
- Keywords
- minority breast cancer patients, EEG, Evaluation, Questionnaires, 11-139
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- The City College of New York, Ralph Lauren Center for Cancer Care and Prevention, Lincoln Medical and Mental Health Center
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients who will receive chemo | – | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireThis 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. |
| Patients who will not receive chemo | – | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireThis 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. |
| Healthy Controls | – | Other: EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireThis 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. |
Who may qualify
- Ages
- 18 to 61 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- MSKCC clinic, The Ralph Lauren Center for Cancer Care and Prevention (RLCCCP)located in Harlem and Lincoln Hospital located in the Bronx.
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireParticipants 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. | Other | Patients who will receive chemo |
| EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireParticipants 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. | Other | Patients who will not receive chemo |
| EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical QuestionnaireParticipants 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. | Other | Healthy Controls |
Primary outcome
neuropsychologic (NP) features
Time frame: 2 years
through administration of NP and psychological instruments and EEG
1 secondary outcome
electrophysiologic features
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Ryan, PhD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychologic (NP) features (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012.