Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Decision regret
研究概览
简要总结
This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.
详细描述
PRIMARY OBJECTIVE:
I. Determine the effect of provision of quality-of-life (QOL) information versus usual care for standard of care surgery or SBRT treatment on decision regret.
SECONDARY OBJECTIVES:
I. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.
II. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years
- •Radiographic stage I-II non-small cell lung cancer (NSCLC)
- •Of note, separate tumor nodule(s) in an ipsilateral lobe different from that of the primary is considered T4 disease. However, these are treated as separate stage I or II lesions and will be eligible for this study.
- •Eligible for both surgery and SBRT
- •Able to provide informed consent in English
- •Have verbal fluency in English
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Radiographic stage III-IV NSCLC except as noted above
- •Eligible for either only surgery or SBRT, but not both
- •Eligible for palliative-intent treatments or supportive care only.
- •Pregnant female participants.
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the investigator's opinion deems the participant an unsuitable candidate
- •Cognitively impaired adults/adults with impaired decision-making capacity
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
研究组 & 干预措施
Group A (QOL fact sheet)
Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).
干预措施: Questionnaire Administration (Other)
Group A (QOL fact sheet)
Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).
干预措施: Informational Intervention (Other)
Group B (usual care)
Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.
干预措施: Best Practice (Other)
Group B (usual care)
Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Decision regret
时间窗: At 6 months
Compare the extent of decision regret based on Decision Regret Scale between the provision of quality of life (QOL) information versus usual care for standard of care surgery or stereotactic body radiation therapy (SBRT) treatment. The five-point decision regret score will be converted to a 100-point score as described by others, where a higher score reflects an increased decision regret. In this schema, a decision regret score \> 25 % is deemed moderate to severe regret. The dichotomized decision regret will be modeled as a function of group, time, and their interaction using a generalized estimating equations (GEE) logistic regression model with an autoregressive covariance structure. The rates of less than moderate to severe regret will be compared between groups at 6-months using a one-sided test about the appropriate contrast of model estimates.
次要结局
- Quality of Life (EORTC QLQ-C30)(Up to 6 months)
- Quality of Life (QOL)(Up to 6 months)
- Difference in consideration of regret(Up to 6 months)