Behavioral Relaxation Approaches for Insomnia in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline Sleep Onset Latency at 14 days
研究概览
简要总结
This is a randomized, 30-day research study that is exploring the effects of two simplified mindfulness interventions in lung cancer patients aimed to improve their sleep quality and anxiety regarding sleep. The investigators will be enrolling a total of 20 patients who have insomnia symptoms. Patients will use a behavioral intervention to help with their sleep.
详细描述
The objective is to implement and examine the outcomes of a simplified relaxation intervention, Assisted Relaxation Therapy (ART), for lung cancer patients who experience insomnia symptoms and other sleep difficulties. This intervention includes using a smartphone application. A variety of surveys will be used to track the interventions' efficacy throughout the study. To test these interventions, the investigators will recruit participants (n=20) from a weekly oncology patient list located within the University of Pennsylvania. Participants with a history of lung cancer who are recruited into the study must have a smartphone. Participants will use the ART intervention over the course of 2 weeks and will receive surveys at enrollment (D0), end of intervention (D14) and 2 weeks post-intervention (D30). Missing data will be handled using imputation methods. The investigators will analyze the data using statistical programs to determine progress throughout the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or older
- •Diagnosed with Lung Cancer (In remission, Undergoing Immune Modulated Chemotherapy, Undergoing Platinum-based Chemotherapy
- •Fluent in English
- •Has Access to Smartphone
- •Has internet connection at home
- •More than 4 weeks post-surgery
排除标准
- •Inability to speak English or communicate verbally
- •Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the guided compassion training due to deafness)
结局指标
主要结局
Change from Baseline Sleep Onset Latency at 14 days
时间窗: 14 days
Changes in sleep onset latency will be measured by sleep diary.
次要结局
未报告次要终点
研究者
Nalaka Gooneratne
Principal Investigator
Abramson Cancer Center at Penn Medicine