An Interventional Trial Using Guided Meditation During Radiation Therapy for Brain Tumors
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Brain Neoplasms
- 发起方
- University of Utah
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in acute anxiety, measured by score on individual item derived from GAD-2, in participants receiving mindfulness intervention during RT compared to standard of care control conditions.
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors.
The main question it aims to answer is:
• What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions?
Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.
研究者
入排标准
入选标准
- •Participant aged ≥ 18 years.
- •Radiologically confirmed tumor of the brain. Note: Participants may have tumor resected after diagnosis.
- •Eligible to undergo radiation treatment for brain tumor for 25-33 treatments.
- •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 ≤
- •MoCA mini score ≥ 11
- •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.
- •An unstable illness that, in the opinion of the investigator, would interfere with study treatment.
- •Prior radiation therapy to the brain.
- •Inability to understand and/or speak the English language.
结局指标
主要结局
Change in acute anxiety, measured by score on individual item derived from GAD-2, 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 RT for brain tumor patients with mask anxiety. Acute anxiety during RT will be measured each RT visit with an individual item ("How nervous, anxious or on edge do you feel right now?" scored on a 0-10 scale) derived from the Generalized Anxiety Disorder 2-item (GAD-2) scale, "0" meaning "Not at All" and "10" meaning "Very Much") measured before and after RT. The change from before to after RT will be averaged over all RT visits.
次要结局
- Change in self transcendence and the magnitude/degree of change in self transcendence as measured by total score of the Nondual Awareness Dimensional Assessment (NADA.)(7 weeks)
- Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care, measured using the total score of the GAD-2 scale prior to RT(7 weeks)
- Change in anxiety during RT and in everyday life as measured by the modified MPoD(7 weeks)