Pilot Feasibility Evaluation of a Mindfulness (Mindfulness) Intervention in Women Preparing for Chemotherapy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Participation rate
研究概览
简要总结
This clinical trial tests how well a mindfulness intervention helps the prevention of chemotherapy-brain (chemo-brain) in women preparing for chemotherapy for breast cancer. Cognitive dysfunction after chemotherapy has been well-documented. Factors that have been used to document and/or have been correlated with chemo brain include self-report and structural brain changes including volume loss. Mindfulness is a type of meditation practice that can be learned to support well-being and decrease stress. Mindfulness is an approach that helps the person increase their awareness of the present moment without judgement. There are data that mindfulness may increase attention and concentration which may prevent some of the side effects from chemotherapy
详细描述
PRIMARY OBJECTIVES:
I. Assess the feasibility of an 8-week mindfulness intervention in women preparing for chemotherapy for breast cancer.
II. Evaluate cognitive dysfunction related factors as an exploratory objective: cognitive function, quality of life, inflammatory markers, functional magnetic resonance imaging (fMRI) brain imaging, and a record of mindfulness practice.
OUTLINE:
Patients participate in a mindfulness program composed of topics that include mindfulness of breathing and the body scan, mindful eating, mindful activity, mindfulness in daily life, expanding the field of awareness, and maintaining a flexible mindfulness practice weekly over 2.5 hours for 8 weeks. Patients also undergo blood sample collection and fMRI on the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Breast cancer diagnosis preparing to undergo chemotherapy
排除标准
- •Under the age of 18
- •Cannot provide informed consent
结局指标
主要结局
Participation rate
时间窗: Up to 1 year
Will be determined by 75% of the participants will participate in at least 6 of the 8 mindfulness sessions.
次要结局
未报告次要终点