Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Medical Outcomes Study Scores - Intervention versus Control
研究概览
简要总结
Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.
详细描述
MBCR is a step wise standardized behavioral intervention of MBSR. The program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. During class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. In addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. A full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage I-III breast cancer, gynecologic cancer or colorectal cancer
- •Cancer survivor at least 18 years of age at the time of study enrollment
- •Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed)
排除标准
- •Psychologic disease in which informed consent cannot be obtained from the subject
- •Need for ongoing chemotherapy and/or radiation therapy
研究组 & 干预措施
Intervention Arm
Subjects are randomized to the Mindfulness Based Cancer Recovery (MBSR) intervention. Participants are presented with mindfulness medication techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. A full day silent retreat will occur in the second half of the course, providing an opportunity for class participants to gain experience with mindfulness techniques.
干预措施: Mindfulness Based Cancer Recovery (Behavioral)
Control Arm
No intervention is administered. Health-related quality of life questionnaires will be completed.
结局指标
主要结局
Change in Medical Outcomes Study Scores - Intervention versus Control
时间窗: Day 1, Week 8 and 4 Month Follow-Up
MOS SF-36: Medical Outcomes Study 36-Item Short-Form
次要结局
- Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Change in State-Trait Anxiety Inventory Scores - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Comparison of Sexual Functioning Scale Scores - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Change in Self-Compassion Scale Scores - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Change in Self-Collected Information - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)
- Change in Number of Natural Killer Cells - Intervention versus Control(Day 1, Week 8 and 4 Month Follow-Up)