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Clinical Trial 16933

Cancer Type: Breast
Study Type: Other
NCT#:

Phase: N/A
Principal Investigator: Jim, Heather

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

Older Breast Cancer Patients: Risk For Cognitive Decline

Summary

The purpose of this study is to evaluate the effect of chemotherapy and hormonal treatment on the mind ("cognition") in older breast cancer patients. This research is being done because breast cancer is a major health problem facing older women and chemotherapy and hormonal treatments are some of the possible treatments offered to women. Because very few women 60 years of age and older have been invited to join past breast cancer studies, we don't have much information available on the effect of chemotherapy and hormonal treatment on the mind ("cognition").

Objective

1. To use patient and control data to measure the magnitide of the impact of systemic therapy on cognition. 2. To use patient data to explore whether cognitive decline varies by category of systemic therapy. 3. To use data from patients to examine whether cognitive decline is associated with QOL at follow up. 4. To use patient and control data to explore whether APOE polymorphisms moderate cognitive declines.

Treatments

Therapies

Medications

Inclusion Criteria

FOR CANCER PATIENTS:

Age 60+ at diagnosis of a new primary histological confirmed breast cancer

Being female

AJCC stages 0-3

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 anxiolitics), dose must have been stable at least two months prior to enrollment.

FOR CONTROLS:

Age 60+

Being female

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 anxiolitics), dose must have been stable at least two months prior to enrollment.

Exclusion Criteria

FOR ALL PARTICIPANTS:

Participant report of a history of formal diagnosis of neurodegenerative disorders that affect cognition (i.e. Alzheimer's disease, Parkinson¿s disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)

Participant report of a history of stroke or moderate to severe head trauma (loss of consciousness > 60 min or with evidence of structural brain changes on imaging)

Major depressive disorder (untreated or poorly treated), history of bipolar disorders, schizophrenia and other psychotic disorders, or substance abuse disorders (self reported and/or stated in medical record).

Participant report of a history of prior breast or other cancer (except non-melanoma skin)

Two synchronous primaries in the same or opposite breast

Visual, auditory, or other impairment that would preclude ability to complete interviews or neuropsychological testing, such as women with history of significant macular degeneration or being unable to correct hearing with hearing aids

Non-English speaking

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.