CLEAR-LUNG (Community-Level Effectiveness to Advance Reach in Lung Cancer Screening)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Effectiveness of Witness Project Lung: Screening Uptake
研究概览
简要总结
The long-term objective is to improve lung cancer screening uptake among screening-eligible Black adults and thereby reduce the population burden of late-stage diagnosis and mortality. The short-term objective of this study is to rigorously test the effectiveness, mechanisms, and implementation readiness of Witness Project® Lung.
详细描述
This study will conduct a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a community-based culturally crafted educational intervention (Witness Project® Lung) compared to a community-based general cancer screening educational program (as the control) for increasing adoption of lung screening within the Black American community while gathering information on its delivery and potential for implementation in a real-world setting. The target population is Black American lung screening eligible individuals. This study will use both quantitative and qualitative methods for data collection and analysis to address the study aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 years to 80 years
- •Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
- •20 pack-year smoking history
- •Able to speak and understand English
- •Self-identify as a Black or African American individual
排除标准
- •Diagnosed with lung cancer
- •Unable to speak and understand English
- •Individuals who do not read English will be able to participate in the study. If an individual indicates they cannot read English, the Study Information Sheet will be read to them allowing ample time for questions prior to their decision to enroll in the study or not.
研究组 & 干预措施
Witness Project Lung
This is a 60 minute comprehensive educational program about lung cancer and screening that leverages the cancer and cancer screening experience of Black Americans through testimonials and 'witnessing' to community members in faith- or community-based settings. Each Witness Project® Lung program is conducted by a Witness Role Model and supported by a Community Health Worker from the community-based health system.
干预措施: Witness Project Lung (Behavioral)
General Educational Program
A 60-minute general educational program about cancer screening will be conducted by the CHW. The educational program consists of a didactic presentation about all screen-detectable cancers (breast, cervical, colorectal, lung, prostate) and their screening test(s) including eligibility criteria, guidelines, and how to get screened followed by a question-and-answer session.
干预措施: General Educational Program (Behavioral)
结局指标
主要结局
Effectiveness of Witness Project Lung: Screening Uptake
时间窗: At baseline
Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan).
Effectiveness of Witness Project Lung: Screening Uptake
时间窗: At six-months post-intervention
Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan).
次要结局
- Stage of Adoption for Decision-Making About Lung Screening(At baseline)
- Stage of Adoption for Decision-Making About Lung Screening(Up to 24 hours post-intervention)
- Stage of Adoption for Decision-Making About Lung Screening(At six-months post-intervention)
- Medical Mistrust(At baseline)
- Medical Mistrust(Up to 24 hours post-intervention)
- Medical Mistrust(At six-months post-intervention)
- Perceived Smoking-Related Stigma(At baseline)
- Perceived Smoking-Related Stigma(Up to 24 hours post-intervention)
- Perceived Smoking-Related Stigma(At six-months post-intervention)
- Knowledge of Lung Cancer and Lung Screening(At baseline)
- Knowledge of Lung Cancer and Lung Screening(Up to 24 hours post-intervention)
- Perceived Barriers to Lung Cancer Screening Scale(At baseline)
- Perceived Barriers to Lung Cancer Screening Scale(Up to 24 hours post-intervention)
- Perceived Barriers to Lung Cancer Screening Scale(At six-months post-intervention)
- Social Influence Scale(At baseline)
- Social Influence Scale(Up to 24 hours post-intervention)
- Social Influence Scale(At six-months post-intervention)
- Sharing Screening Information with Others(At six-months post-intervention)
- Built Environment(At baseline)