Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
研究概览
简要总结
This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral therapy may reduce anxiety and improve the well-being and quality of life of patients who have stage IV non-small cell lung cancer and their caregivers.
详细描述
PRIMARY OBJECTIVES:
I. To identify, through both quantitative and qualitative methods, clinical correlates of anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer and their primary caregivers.
II. To apply these findings to develop a brief dyadic intervention based on Cognitive Behavioral Therapy (CBT) to reduce anxiety in late-stage lung cancer patients and their primary caregivers.
III. To evaluate the feasibility and acceptability of the pilot intervention through number of completed visits and assessment pre- and post- intervention.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage IV non-small cell lung cancer
- •At least 6 weeks post-diagnosis
- •Current symptoms of anxiety (e.g., Hamilton Rating Scale for Anxiety [HAM-A] >=14)
- •Ability to understand and the willingness to sign a written informed consent document
- •CAREGIVER: Identified by patient as primary caregiver
- •CAREGIVER: At least 14 hours/week spent caring for patient
- •CAREGIVER: Current symptoms of anxiety (e.g., HAM-A >= 14)
- •CAREGIVER: Ability to understand and the willingness to sign a written informed consent document
排除标准
- •PATIENTS AND CAREGIVERS:
- •Active, unstable, untreated serious mental illness
- •Other cognitive inability to complete informed consent process or study procedures
研究组 & 干预措施
Supportive care (cognitive behavioral therapy)
Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.
干预措施: counseling intervention (Other)
Supportive care (cognitive behavioral therapy)
Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.
干预措施: questionnaire administration (Other)
Supportive care (cognitive behavioral therapy)
Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
时间窗: Up to 7 weeks
Acceptability, based on qualitative analysis of exit interviews
时间窗: Up to 7 weeks
次要结局
未报告次要终点
研究者
Ellen Hendriksen
Instructor, Psychiatry & Behavioral Science - Behavioral Medicine
Stanford University