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Observational Study: Cognitive Decline in Older Breast Cancer Patients

This study is looking at how breast cancer treatments might affect memory and thinking skills in women aged 60 and older. Researchers want to understand if these treatments lead to changes in attention, processing speed, executive function (planning and problem-solving), learning, and memory over time. They will also explore how these changes might impact your quality of life. The study aims to enroll 1700 women across the country who have been diagnosed with early-stage breast cancer (stages 0-3) or are planning neoadjuvant therapy (treatment before surgery). This is an observational study, meaning there are no specific interventions or drugs being tested. The goal is to learn more about how different factors, including genetics, inflammation, sleep, and physical health, might influence cognitive outcomes.

Study design
This is an observational study aiming to enroll 1700 women. It is not testing a specific drug or treatment.
What's involved
You would complete assessments at the beginning of the study and then annually for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed annually for up to 5 years to measure changes in cognitive abilities.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03451383

Older Breast Cancer Patients: Risk for Cognitive Decline

Recruiting
Not specifiedAges 60+Observational
Georgetown University
~1,700 participants
Updated 2025-03-11 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Attention, Processing Speed, Executive Function (APE) Domain
Measured over Baseline and annually up to 5 years
+2 more outcomes measured

Conditions

Cancer, Breast
Age-related Cognitive Decline
Cognitive Decline

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Jeanne Mandelblatt · PRINCIPAL_INVESTIGATOR · Lombardi Comprehensive Cancer Center

Who to contact

Jeanne Mandelblatt
[email protected]
2026870801
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

being female
Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
AJCC stages 0-3 or planning neoadjuvant therapy
In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.
Participant report of no previous or current chemotherapy or hormonal treatment use (anastrazole, exemestane, etc.) This does not include hormonal replacement therapy, synthetic thyroid hormones, etc.
being female
Age 60+
In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.

Exclusion

Participant report of a history of formal diagnosis of neurological problems (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors, etc.)
Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.)
Participant report of a history of stroke (with the exception of TIA if ≥1 year ago)
Participant report of HIV/AIDS
Participant report of moderate to severe head trauma (loss of consciousness \> 60 min or with evidence of structural brain changes on imaging)
History of major psychiatric disorder (DSM-IV Axis 1) (i.e. major depressive disorder (untreated or poorly treated), bipolar disorders, schizophrenia, or substance abuse disorders (self-reported and/or stated in medical record).
Participant report of a history of prior breast or other cancer with the exception of non-melanoma skin cancer. An exception for cases only: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy. This previous cancer cannot be breast cancer.
Participant report of previous or current chemotherapy or hormonal therapy use
Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
Visual or hearing impairment that would preclude ability to complete interviews or neuropsychological testing, such as significant macular degeneration or being unable to correct hearing with hearing aides
Non-English speaking
To participate in the optional neuroimaging portion of the study:

What this trial measures

  • Change in Attention, Processing Speed, Executive Function (APE) DomainBaseline and annually up to 5 years

    Using neuropsychological tests: NAB Digits Forward and Backward, Trailmaking A and B, Digit Symbol Subtest-Wechsler Adult, The Timed Instrumental Activities of Daily Living, Controlled Oral Word Association Test, NAB Driving Scenes and NAB Figure Drawing. These measures are aggregated to arrive at one reported value. The individual tests are first selected via factor analysis, then the selected raw scores are standardized to baseline controls by age and education group. The final domain score is calculated by averaging available individual z-standardized test scores.

  • Change in Learning and Memory (LM) DomainBaseline and annually up to 5 years

    Using neuropsychological tests: Logical Memory I and II (Wechsler Memory Scale), NAB List Learning (Immediate Recall, Short Delay Recall, Long Delay). These measures are aggregated to arrive at one reported value. The individual tests are first selected via factor analysis, then the selected raw scores are standardized to baseline controls by age and education group. The final domain score is calculated by averaging available individual z-standardized test scores.

  • Change in Cognition DomainBaseline and annually up to 5 years

    Using assessment: FACT-Cog and PCI Sub-scale. The measures are aggregated to arrive at one reported value. Change in cognition is calculated based on the official FACT-Cog scoring manual. The total score is calculated by summing the available items among all 37 items when no more than 30 items are missing. The PCI subscale score is calculated by summing the available items among all 18 items when no more than 8 items are missing.