Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms

PRIMARY OBJECTIVES:

I. To objectively assess changes in cognitive performance and quality of life (QOL) pre and
post participation in a cognitive rehabilitation intervention in gynecologic and breast
cancer survivors who have undergone chemotherapy.

II. To measure changes in neural function as measured by functional magnetic resonance
imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral
responses while performing cognitive tasks.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once
weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline
(Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).

ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour
duration group focusing on the brain and cognition. Patients complete cognitive tests and
questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).

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)