A Study of Attention and Memory Processes in Breast Cancer Survivors

NCT ID: NCT04883398

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2026-05-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

No interventions assigned to this group

Healthy controls

Healthy controls ages 50-70 with no history of cancer.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Baruch College City University of New York

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Root, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

21-161

Identifier Type: -

Identifier Source: org_study_id