Med-RT BG: An Interventional Trial Using Guided Meditation During Radiation Therapy for Breast and Gynecological Malignancies
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
研究概览
简要总结
The goal of this study is to assess the effect of brief mindfulness-guided meditations during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participant aged ≥ 18 years.
- •Diagnosis of breast or gynelogical cancer.
- •Eligible to receive 15-25 daily radiation therapy treatments for breast or gynelogical cancer.
- •Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment.
- •Karnofsky performance score ≥ 60 or ECOG performance score ≤
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Active suicidal ideation or active psychotic state in the opinion of the investigator.
- •Patient is receiving deep inspiration breath hold treatment.
- •An unstable illness that, in the opinion of the investigator, would interfere with study treatment.
- •Prior radiation therapy.
- •Inability to understand and/or speak the English language.
结局指标
主要结局
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
时间窗: 7 weeks
To assess the acute anxiolytic effects of a brief mindfulness intervention during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers. Acute anxiety during RT will be measured at each treatment visit with an individual item ("How nervous, anxious or on edge do you feel right now?" scored on a 0 (not at all) to 10 (Very much). derived from the Generalized Anxiety Disorder 2-item (GAD-2) scale, measured before and after RT. The change from before to after RT will be averaged over all treatment visits.
Change in acute anxiety in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
时间窗: 7 weeks
To assess the acute anxiolytic effects of a brief mindfulness intervention during radiation therapy (RT) for patients with anxiety related to RT for breast and gynecological cancers. Acute anxiety during RT will be measured at each treatment visit with an individual item ("How nervous, anxious or on edge do you feel right now?" scored on a 0 (not at all) to 10 (Very much). derived from the Generalized Anxiety Disorder 2-item (GAD-2) scale, measured before and after RT. The change from before to after RT will be averaged over all treatment visits.
次要结局
- Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.(7 weeks)
- Change in anxiety during RT and in everyday life as measured by the modified MPoD(7 weeks)
- Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care control conditions.(7 weeks)
- Change in anxiety during RT and in everyday life as measured by the modified MPoD(7 weeks)
- Change in self transcendence and the magnitude/degree of increased self transcendence will predict degree of anxiety in the course of daily life as measured by total score of the Nondual Awareness Dimensional Assessment (NADA).(7 weeks)