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Complete title: Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
|Research Study Number||7750|
|Principal Investigator||Heidi Gray, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Female
- Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment
- Prior treatment of gynecologic or breast cancer with chemotherapy
- Completion of treatment (e.g., chemotherapy, radiation therapy, surgery, etc.) for gynecologic or breast cancer 6 months or greater in the past
- Able to comprehend and speak English
- For the subset of participants who will undergo magnetic resonance imaging (MRI), ability to withstand lying down in small area (MRI scanner) for 50 minutes
- Completion of successful fMRI safety screening
- Able to give informed consent
- Able to undergo informed consent procedures and 3 hours of testing, plus 8 1-hour cognitive rehabilitation sessions with breaks
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Cancer onset before the age of 21
- Unstable medical problems (such as unstable heart disease, unstable hypertension, diabetes in poor control, respiratory disease complicated by hypoxia or hypercapnia, infectious illnesses, unstable thyroid dysfunction, currently hospitalized)
- History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization; mild depression or stable anti-depressants, and anti-seizure medications are acceptable; anti-anxiety medications may be acceptable
- Current alcohol over-use as defined by currently consuming 4 drinks or more per day or binge drinking (6 or more drinks in one night) within the past week
- History of or current neurological illness that significantly impacts cognition (e.g. stroke, multiple sclerosis, Parkinson's disease, Alzheimer's disease, head injury, epilepsy, etc)
- History of brain injury that significantly impacted cognition; as indicated responses on the Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) greater or equal to any of the following: 30 minutes or more of loss of consciousness (LOC), two or more mild cases within two weeks of each other, or any injury with loss of consciousness before the age of 15
- History of central nervous system (CNS) tumor
- A score of 25 or more on the Patient Health Questionnaire (PHQ-9) on the first visit
- A score of 26 or below on the Mini Mental Status Exam (MMSE) triggers a review by an investigational team before enrolling
- A score above 45 on the Wender Utah Rating Scale for attention deficit disorder (ADD) (WURS)
- For the subset of participants undergoing neuroimaging:
- * Medical history or devices which make an MRI unsafe or uncomfortable (e.g., magnetic rods or pins, metal plates or screws, pacemaker)
Other exclusion criteria may apply.
Breast Cancer; Gynecological Cancer; Ovarian Cancer; Solid Tumors; Genital Neoplasms, Female; Cancer Survivor; Chemo-brain
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