Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Feasibility of the conversation tool
研究概览
简要总结
This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.
II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the conversation tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
- •PART I: English fluency
- •PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
- •PART II: English fluency
- •PART II: > 6-month life expectancy
- •PART II: Score of > 3 on the 6-Item Screener for Cognitive Impairment
排除标准
- 未提供
结局指标
主要结局
Feasibility of the conversation tool
时间窗: At enrollment
The number of patients enrolled divided by the number of patients offered enrollment.
Acceptability of the conversation tool
时间窗: At enrollment
The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.
次要结局
- Decisional Regret(At the end of follow-up at 8 weeks)
- Decisional conflict(At the end of follow-up at 8 weeks)
- Decision making involvement(From enrollment to the end of follow-up at 8 weeks)
- Values-treatment concordance(From enrollment to the end of follow-up at 8 weeks)
- Anxiety(From enrollment to the end of follow-up at 8 weeks)
- Shared decision-making quality(At the end of follow-up at 8 weeks)
- Perceived involvement in care(At the end of follow-up at 8 weeks)
- Self-efficacy(From enrollment to the end of follow-up at 8 weeks)
研究者
Donald R Sullivan, MD, MA, MCR
Principal Investigator
OHSU Knight Cancer Institute