RADY-GU-SAYKIN-TLC; Older breast cancer patients: Risk for cognitive decline
A
Andrew Saykin, PsyD
Primary Investigator
Overview
We are looking for healthy women (who have never had cancer) to participate in a study of at Indiana University School of Medicine. We are working to better understand cognitive changes after breast cancer treatment.
Description
The purpose of this study is to evaluate the impact of systemic therapy on cognitive functioning in older breast cancer patients.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
breast cancer,healthy,healthy,breast cancer,cancer,oncology,healthy,breast cancer,cancer,oncology
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Age: Between 60 Years - 100 Years
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Gender: Female
Inclusion Criteria
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 Criteria
Participant report of a history of formal diagnosis of neurodegenerative disorder(s) that affect cognition (i.e. Alzheimer?s disease, Parkinson?s disease, multiple sclerosis, dementia, seizure disorder, 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 disorder, schizophrenia or other psychotic disorder, or substance abuse disorder (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 five 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 (Rituxan) for rheumatoid arthritis, psoriasis or Crohn?s disease, or cyclophosphamide (Cytoxan, Neosar) for lupus
Two different 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 aides
Non-English speaking
To participate in the optional neuroimaging portion of the study:
Participant cannot be claustrophobic
Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe
Participant cannot have any type of implanted electrical device
Additional Information: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 Criteria
Participant report of a history of formal diagnosis of neurodegenerative disorder(s) that affect cognition (i.e. Alzheimer?s disease, Parkinson?s disease, multiple sclerosis, dementia, seizure disorder, 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 disorder, schizophrenia or other psychotic disorder, or substance abuse disorder (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 five 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 (Rituxan) for rheumatoid arthritis, psoriasis or Crohn?s disease, or cyclophosphamide (Cytoxan, Neosar) for lupus
Two different 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 aides
Non-English speaking
To participate in the optional neuroimaging portion of the study:
Participant cannot be claustrophobic
Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe
Participant cannot have any type of implanted electrical device
Participants will be paid for their participation.
Updated on
04 May 2024.
Study ID: 1602851718
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