Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT01641068
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
* 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT01641068
Study Brief:
Protocol Section:
NCT01641068