Randomized Trial of an Intervention to Enhance Quality of Life in Adults Completing Lung Cancer Treatment With Curative Intent
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
研究概览
简要总结
The aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.
详细描述
This is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance.
In this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program.
It is expected that about 100 people will take part in this research study.
The American Lung Association is supporting this research by providing funding for the research study.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or older
- •Able to read and respond in English
- •Diagnosis of non-small cell lung cancer or small cell lung cancer
- •Documented curative treatment plan including systemic therapy +/- radiation and +/- surgery
- •Completed cancer treatment within past 3 weeks
- •If final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete
- •If final treatment is surgery: within 3 weeks after hospital discharge following surgery
排除标准
- •Comorbid health condition that would interfere with study participation
- •Current participation in cognitive behavioral therapy treatment
结局指标
主要结局
Quality of life: Functional Assessment of Cancer Therapy-Lung Cancer
时间窗: Up to 12 weeks
We will investigate longitudinal differences in quality of life between study groups (Functional Assessment of Cancer Therapy-Lung Cancer score range 0-144, with higher scores indicating better quality of life)
次要结局
- Fear of cancer recurrence: Fear of Cancer Recurrence Scale 7(Up to 12 weeks)
- Symptom burden: Edmonton Symptom Assessment Scale(Up to 12 weeks)
- Psychological symptom burden: Hospital Anxiety and Depression Scale(Up to 12 weeks)
- Social support: Multidimensional Scale of Perceived Social Support(Up to 12 weeks)
- Social isolaton: Campaign to End Loneliness Measurement Tool(Up to 12 weeks)
研究者
Lara Traeger
Principal Investigator
Massachusetts General Hospital