Breast Cancer SurvivorsNCT04883398
A Study of Attention and Memory Processes in Breast Cancer Survivors
An observational study of Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to observe the attention and memory processes in breast cancer survivors. Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so we can compare the results of testing on each group of participants. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer survivors and Healthy volunteers
Who may be able to join
- For All Paricipants:
- As per medical record or self-report, female
- As per medical record or self-report, age 50-70
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- English fluent (as per self reported fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff/preference of English language for healthcare)**
- As per medical record or self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants and anxiolytics) on a daily basis, dose must have been stable at least two months prior to enrollment
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- For Survivors:
- As per medical record or self-report, AJCC stages 0-3 breast cancer
- As per medical record or self-report, at least 1-year post-treatment for breast cancer (including surgery, and chemotherapy, with or without radiation
- As per medical record or self-report, current endocrine therapy
- For Healthy Controls:
- As per self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment.
- As per self report, no history of cancer except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma
Who cannot join
- For All Participants:
- As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)
- As per medical record or self report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation
- As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder
- As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aides)
- As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus
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- As per medical record or self-report, participation in a conflicting research study (i.e. another neurocognitive study utilizing HVLT and BVMT tasks.)
- For Survivors only:
- As per medical record or self-report, history of another type of cancer or prior breast cancer diagnosis except non-melanoma/basal cell skin cancer/squamous cell skin carcinoma
- As per medical record or self-report, disease recurrence.
- For Healthy Controls only:
- As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Neural and Cognitive Mechanisms of Attention and Memory Deficits in Cancer Survivors
The purpose of this study is to observe the attention and memory processes in breast cancer survivors. Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so we can compare the results of testing on each group of participants.
- Conditions
- Breast Cancer Survivors
- Keywords
- Neural and Cognitive Mechanisms, Memory Deficits, 21-161
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Breast cancer survivors ages 50-70 with AJCC stages 0-3 breast cancer who are at least 1 year post-treatment (including surgery, radiation, and chemotherapy, with or without current endocrine therapy) | |
| Healthy controls | Healthy controls ages 50-70 with no history of cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
test early attentional deficits
Using EEG measures of brain activity during a cognitive-experimental long-term memory task to evaluate the mechanisms underlying attention, initial learning, retrieval, and metamemory performance. P3 amplitude as measured by EEG at the Pz electrode.
Measured: baseline
abnormal event-related potential (ERP) during initial learning
During passive tasks (such as a paired-click paradigm)The proposed paradigm is adapted from previous work using EEG to measure the relationship between attention, learning, and subsequent performance on a verbal long-term memory task in healthy adults41. Relative to standard neuropsychological measures, this technique provides a more finely grained approach to investigating the effect of attentional mechanisms on subcomponents of initial learning and retrieval processes in long-term memory.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start6 May 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baruch College City University of New York
- Responsible party
- Sponsor
- Investigators
- James Root, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883398
- Sponsor's protocol ID
- 21-161
- Status last verified
- Nov 2026
- First submitted
- 6 May 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural and Cognitive Mechanisms of Attention and Memory Deficits in Cancer Survivors
- ClinicalTrials.gov ID
- NCT04883398
- Acronym / sponsor ID
- 21-161
- Conditions
- Breast Cancer Survivors
- Keywords
- Neural and Cognitive Mechanisms, Memory Deficits, 21-161
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Baruch College City University of New York
- Study start
- 6 May 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 May 2021 (actual)
- 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.
The purpose of this study is to observe the attention and memory processes in breast cancer survivors. Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so we can compare the results of testing on each group of participants.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | –Breast cancer survivors ages 50-70 with AJCC stages 0-3 breast cancer who are at least 1 year post-treatment (including surgery, radiation, and chemotherapy, with or without current endocrine therapy) |
| Healthy controls | – | –Healthy controls ages 50-70 with no history of cancer. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors and Healthy volunteers
Key inclusion criteria (13 listed)
- As per medical record or self-report, female
- As per medical record or self-report, age 50-70
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- English fluent (as per self reported fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff/preference of English language for healthcare)**
- As per medical record or self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants and anxiolytics) on a daily basis, dose must have been stable at least two months prior to enrollment
Key exclusion criteria (12 listed)
- As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)
- As per medical record or self report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation
- As per medical record or self report, a diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder
- As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aides)
- As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
test early attentional deficits
Time frame: baseline
Using EEG measures of brain activity during a cognitive-experimental long-term memory task to evaluate the mechanisms underlying attention, initial learning, retrieval, and metamemory performance. P3 amplitude as measured by EEG at the Pz electrode.
abnormal event-related potential (ERP) during initial learning
Time frame: baseline
During passive tasks (such as a paired-click paradigm)The proposed paradigm is adapted from previous work using EEG to measure the relationship between attention, learning, and subsequent performance on a verbal long-term memory task in healthy adults41. Relative to standard neuropsychological measures, this technique provides a more finely grained approach to investigating the effect of attentional mechanisms on subcomponents of initial learning and retrieval processes in long-term memory.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
James Root, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site 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 Survivors, run by Memorial Sloan Kettering Cancer Center at 1 site 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 13 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
test early attentional deficits (time frame: baseline). The study lists 2 primary outcomes in all. 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 4 Nov 2026.