Mindful Movement Program for Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Effects of this program on attention and attitude
研究概览
简要总结
RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention, and attitude) and physical movement. A mindful movement program may be effective in improving well-being in older women who are breast cancer survivors.
PURPOSE: This randomized clinical trial is studying how well a mindful movement program works in improving quality of life in older female breast cancer survivors.
详细描述
OBJECTIVES:
- To test the effects of the 12-week Mindful Movement Program on quality of life in older female breast cancer survivors.
- To test the effects of this program on mindfulness outcomes in these participants.
- To compare mindfulness qualities in the experimental group with the control group.
- To determine the qualitative benefits of this program as described by these participants.
OUTLINE: Participants are randomized to 1 of 2 intervention arms.
- Arm I (Mindful Movement Program [MMP]): Participants undergo a 2-hour MMP session once weekly for 12 weeks. Participants are encouraged to practice intentional-mindful movement at home 5 minutes daily during weeks 1-4, 10 minutes daily during weeks 5-8, and 15 minutes daily during weeks 9-12. Mindful movement is a self-directed activity incorporating mindfulness concepts and physical movement. Mindfulness consists of the three core elements: intention (reasons for participating in a mindfulness intervention), attention (observing experiences in the present moment), and attitude (nonjudgmental openness and acceptance of experiences). Each MMP session includes verbal sharing with a partner and the group and movement individually and with a partner, while focusing on the elements of mindfulness. Music is incorporated into some portion of each session.
- Arm II (control): Participants undergo no intervention. All participants complete questionnaires for sociodemographic and individual characteristics, quality of life (including psychological, social, spiritual, and physical well-being, anxiety and depression, fear of recurrence, body image, and upper body symptoms), movement, and mindfulness (including attention, self-compassion, and intention) at baseline and weeks 12 and 18.
PROJECTED ACCRUAL: A total of 75 participants (45 in the experimental group and 30 in the control group) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Breast cancer survivor
- •At least 12 months since completion of treatment (chemotherapy, biotherapy [e.g., trastuzumab], or radiotherapy)
- •No evidence of metastatic disease
- •PATIENT CHARACTERISTICS:
- •English speaking
- •Not under acute psychological distress
- •Not using an assistive device (cane, walker, or wheelchair)
- •Able to participate in the Mindful Movement Program by a medical release from the patient's physician
- •Pregnancy allowed
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Concurrent selective estrogen-receptor modulator permitted
- •No other concurrent treatment
排除标准
- 未提供
结局指标
主要结局
Effects of this program on attention and attitude
时间窗: 6 months after study entry
Effects of the Mindful Movement Program on psychological well-being, distress, fear of recurrence, physical well-being, upper-body symptom bother, social well-being, body image, and spiritual well-being at baseline and weeks 12 and 18
时间窗: 6 months after study entry
Perceptions of the program as described by the experimental group
时间窗: 6 months after entry
Differences of attention and attitude between the experimental group and the control group
时间窗: 6 months after study entry
次要结局
未报告次要终点