Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in screening intentions
研究概览
简要总结
The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.
详细描述
Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to participate in this study:
- •Age 55 - 80;
- •Current smoker, or former smoker who has less than a 16-year quit history;
- •Have at least a 30-pack year smoking history (average packs per day * years smoking); and
- •Patient of the Internal Medicine Clinic at University of North Carolina Health Care.
排除标准
- •All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- •Ever diagnosed with lung cancer;
- •Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment;
- •Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment;
- •Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and
- •Had a chest CT scan within the past 18 months prior to enrollment.
研究组 & 干预措施
Pre/Post Test of a Lung Cancer Screening Decision Aid
干预措施: Pre/Post Test of a Lung Cancer Screening Decision Aid (Behavioral)
结局指标
主要结局
Change in screening intentions
时间窗: At time of intervention
We will use descriptive statistics to provide an overview of screening intentions at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening intentions.
Change in decision-making measures of knowledge
时间窗: At time of intervention
We will use descriptive statistics to provide an overview of knowledge at baseline and at follow-up. * Hypothesis 1: Screening specific knowledge will improve after completing the decision aid. o Statistical tests: * Overall knowledge: Treating knowledge as a continuous variable by adding number correct out of 12 items (0-12 possible points), we will perform a Wilcoxon sign rank test to assess change in knowledge between baseline and follow-up * Individual knowledge items: Using McNemar's test, we will compare the proportion who correctly answered individual knowledge items at baseline and follow-up
Change in screening attitudes
时间窗: At time of intervention
We will use descriptive statistics to provide an overview of screening attitudes at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening attitudes.
Change in decisional conflict
时间窗: At time of intervention
We will use descriptive statistics to provide an overview of decisional conflict at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of decisional conflict.
次要结局
- Preliminary estimates on the effect of the decision aid on behavioral outcomes(Within 3 months of intervention)
- Feasibility of implementing a decision aid intervention in a primary care clinic setting(Through study completion, an average of 1 year)