A Study of Attention and Memory Processes in Breast Cancer Survivors

NCT04883398 | Active Not Recruiting

• 1 other identifier: 21-161
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Survivors

Keywords

Neural and Cognitive Mechanisms; Memory Deficits; 21-161

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: Survivors will be recruited in Breast Medicine Service clinics at the Breast and Imaging Center
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors and Healthy volunteers

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Baruch College City University of New York: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Root, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: May 6, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)