Behavioral and Neural Indices of Cognitive Rehabilitation in Women's Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
研究概览
简要总结
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Researchers would like to know if there is a relationship between baseline performance on timed attention and memory tasks before receiving memory and thinking skills workshop designed to improve cognition, and performance on such tasks after the workshop.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
时间窗: Pre-workshop to 7 weeks post-workshop
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire
时间窗: Pre-workshop to 7 weeks post-workshop
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Changes in neural function measured by fMRI BOLD signal
时间窗: Pre-workshop to 7 weeks post-workshop
MRI functional imaging assessments while performing cognitive tasks.
次要结局
未报告次要终点