Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall
研究概览
简要总结
This study will explore the feasibility and potential effects of a simple, home-based daily meditation intervention on breast cancer survivors' cognitive and psychological functioning as well as inflammatory regulation.
详细描述
This study will compare two home based 8-week interventions (Kirtan Kriya meditation vs.
relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed chemotherapy 3 months to 5 years prior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a history of non-inflammatory breast cancer (stages I-IV):
- •Received chemotherapy as part of their treatment
- •Completed chemotherapy treatment 3 months to 10 years prior to study enrollment
- •Individuals who have report cognitive deficits
排除标准
- •Breast cancer survivors with a history of metastases to the brain
- •A physician diagnosis of: dementia, a learning disability, unmanaged major depression, psychosis, schizophrenia, bipolar, traumatic brain injury, cancer of the central nervous system, diabetes, arthritis
- •Taking oral steroids within 30 days of enrolling
- •A regular meditation practice (greater than 1 time per week)
- •Currently taking immune modifying medications
结局指标
主要结局
Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall
时间窗: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
The change of the Hopkins Verbal Learning Test-Revised scores for immediate and delayed recall from baseline to Time 3 (16 weeks after baseline) will be assessed. This test measures immediate and delayed verbal memory. Measured as words recalled and adjusted for age and education. Higher words recalled suggests greater verbal learning and memory performance.
Executive Functioning Performance- Trail Making Test Parts A & B
时间窗: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
The change in Trails A \& B scores, a measure of processing speed and executive attention, from baseline to Time 3 (16 weeks after baseline) will be assessed. Where time until completion is measured and adjusted for age and education. Faster time until completion suggests higher executive function.
Verbal Fluency Performance-Controlled Oral Word Association Test
时间窗: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
The change of the Controlled Oral Word Association Test, a measure of verbal fluency, scores from baseline to Time 3 (16 weeks after baseline) will be assessed. Measured as number of words produced and adjusted for age and education. Higher words produced suggests greater verbal fluency performance.
次要结局
- Interleukin-13 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interferon gamma concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-1 β concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-4 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Granulocyte-macrophage colony-stimulating factor concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-10 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-8 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-2 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-5 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-6 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Interleukin-12 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Self-reported cognitive function(Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).)
- Anxiety Symptoms(Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).)
- Interleukin-7 concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Tumor necrosis factor alpha concentration(Baseline, and Time 2 (8 weeks after baseline).)
- Feelings of depression(Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).)
- Perceived Fatigue(Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).)
- Perceived stress(Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).)
研究者
Ashley M. Henneghan
Assistant Professor
University of Texas at Austin