Influence of Meditation-Based Breathing Training on Target Motion Management and Distress During Radiation for Abdominal and Lung Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching
研究概览
简要总结
This randomized pilot clinical trial studies the effects of meditation-based breathing training on patients' control of their breathing patterns and breathing-related movement, as well as on their psychological distress and treatment experience during radiation therapy. Meditation-based breathing training may decrease breathing-related movement and the amount of stress by improving breathing patterns in patients with abdominal or lung cancer undergoing radiation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the influence of regular breathing cycles using breathing relaxation techniques on efficacy of the respiratory-gated treatment as measured by: (1) real-time position management (RPM) parameters; (2) end inspiration or expiration length; (3) changes in gate width.
SECONDARY OBJECTIVES:
I. To evaluate the effect of breathing relaxation techniques on: (1) psychosocial outcomes; (2) treatment compliance.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •PHASE I - PATIENTS: All patients with abdominal tumors who have undergone at least 4 respiratory-gated radiotherapy treatments
- •PHASE I - PATIENTS: Full comprehension of English language
- •PHASE I - STAFF: All staff who have overseen the delivery of respiratory-gated radiotherapy for at least 6 months
- •PHASE I - STAFF: Full comprehension of English language
- •PHASE II: All patients with abdominal or lung tumors undergoing a respiratory gating simulation
- •PHASE II: Karnofsky performance status > 60%
- •PHASE II: Life expectancy > 3 months
- •PHASE II: No prior radiotherapy to the abdomen/lung
- •PHASE II: Full comprehension of English language
排除标准
- •PHASE I - PATIENTS: Inability to comprehend English language interview questions
- •PHASE I - STAFF: Inability to comprehend English language interview questions
- •PHASE II: Karnofsky performance status < 60%
- •PHASE II: Prior radiotherapy to the abdomen/lung
- •PHASE II: Evidence of progressive or untreated gross disease outside of the abdomen/lung
- •PHASE II: Inability to comprehend English language breathing exercise instructions
- •PHASE II: Concurrent diagnosis of a significant respiratory disorder which requires the use of oxygen
研究组 & 干预措施
Arm I (breathing training sessions)
Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.
干预措施: Educational Intervention (Other)
Arm I (breathing training sessions)
Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.
干预措施: Meditation Therapy (Other)
Arm I (breathing training sessions)
Patients participate in 3 50-minute breathing training sessions, including a psycho-educational component and meditation-based breathing training, over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.
干预措施: Questionnaire Administration (Other)
Arm II (control)
Patients receive standard care over 10 days. Patients then undergo 4D-CT on day 14 and undergo image-guided SBRT or standard radiation therapy 5 times a week for up to 5 fractions or 25 fractions, respectively.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in duty cycle, defined as the fraction of the time of the breathing cycle that the beam is on, before and after breath coaching
时间窗: Baseline to up to 5 weeks
Data will be analyzed using a mixed-model analysis of variance (ANOVA) to test for differences between the two independent groups (with a fixed effect factor of group membership).
Changes in gate width
时间窗: Baseline to up to 5 weeks
Changes in the length of the end expiration or end inspiration defined as when the breathing trace or internal motion change direction
时间窗: Baseline to up to 5 weeks
Data will be analyzed using a mixed-model ANOVA to test for differences between the two independent groups (with a fixed effect factor of group membership).
次要结局
- Change in patients' self-reported levels of psychological distress, physical pain and discomfort, and post-traumatic stress associated with cancer diagnosis and radiation treatment(Baseline to up to 5 weeks)
研究者
Alyson Moadel
Principal Investigator
Albert Einstein College of Medicine