A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Effectiveness of Meditation Sessions
研究概览
简要总结
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment.
This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.
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
- Double (Participant, Investigator)
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
- •Age ≥ 18 years
- •Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
- •Willing to attend MBI sessions weekly during RT
- •Able to transport themselves to scheduled MBI sessions in the DAHLC
- •Able to complete questionnaire(s) by themselves
- •Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
- •ECOG Performance Status 0-2
排除标准
- •Prescribed a course of RT with fewer than 15 consecutive, daily fractions
- •Unable or unwilling to attend required MBI sessions
研究组 & 干预措施
Standard of Care
干预措施: Standard of Care (Other)
Meditation
干预措施: Meditation (Behavioral)
结局指标
主要结局
Effectiveness of Meditation Sessions
时间窗: 3 months and 12 months post radiation treatment.
Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.
Effectiveness of Meditation Sessions
时间窗: Before radiation treatment.
including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer.
Effectiveness of Meditation Sessions
时间窗: During radiation treatment
Comparison of change in total LASA-6 and single question relaxation surveys.
次要结局
未报告次要终点
研究者
Kimberly S. Corbin
Principal Investigator
Mayo Clinic