C-Raven LDCT: Pilot Randomized Control Trial (RCT) of a Lung Cancer Screening Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Number of Participants with Completion of Lung Cancer Screening
研究概览
简要总结
This study is a three-arm, randomized controlled pilot of a lung cancer screening intervention. The investigators will recruit participants ages 50-80 who are likely to meet lung cancer screening guidelines. After eligibility screening, participants will be randomized to one of three educational interventions regarding lung cancer. Lung cancer screening outcomes will be assessed.
详细描述
Smoking is associated with a dramatically increased risk of lung cancer, with rates 10-40 times higher among those who smoke than among those who do not smoke, with smoking accounting for about 85-90% of all lung cancer cases. Screening for lung cancer with low-dose computed tomography (LDCT) has been shown to significantly reduce lung cancer mortality in high-risk populations. Lung cancer screening with annual LDCT is therefore recommended by the US Preventive Services Task Force (USPSTF) for all adults aged 50 to 80 years with a 20 pack-year history of smoking who currently smoke or have quit within the past 15 years. However, in a nationwide study of individuals eligible for lung cancer screening in 2022, only 18% were up-to-date with the recommended screening.
The investigators propose a three-arm, randomized controlled pilot of a lung cancer screening intervention. Recruitment will be carried out primarily through the electronic health record, with invitations sent to patients aged 50-80 who have a documented history of smoking but no chest CT on file within the past 18 months. The investigators will also partner with community organizations such as senior centers and churches to distribute information about the study.
Potential participants will be screened for eligibility for lung cancer screening. If eligible, the participants will undergo a consent process, complete baseline surveys (demographics, etc.), and be randomized to one of the following three study conditions:
- Notification of eligibility for lung cancer screening with a recommendation to discuss with the participant's health care provider
- Animated video on shared decision-making for LDCT with accompanying guide, offered as a downloadable PDF or mailed hard copy, per individual preference
- Video and guide as in (b), plus a one-on-one call with a community health worker (CHW), 1-2 weeks after viewing the materials
Three months after receiving the intervention, follow-up surveys will be sent to assess attitudes toward and completion of lung cancer screening.
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
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Existing record within the Johns Hopkins medical system
- •Age 50-80
- •Current tobacco use OR cessation within the past 15 years
- •20-pack year history of smoking
- •No chest CT imaging within the past 18 months
- •English speaking
- •Willing to complete the study procedures, which include questionnaires and possibly a follow-up call
排除标准
- •Not meeting eligibility criteria
研究组 & 干预措施
Notification of Eligibility
Participants receive notification of eligibility for lung cancer screening with a recommendation to discuss with their health care provider
Video/Brochure
Participants receive an animated video with accompanying guide.
干预措施: Video/Brochure (Behavioral)
Video/Brochure/Follow-up Call
Participants receive an animated video video, an accompanying guide, and a call with a community outreach specialist/community health worker.
干预措施: Video/Brochure/Follow-up Call (Behavioral)
结局指标
主要结局
Number of Participants with Completion of Lung Cancer Screening
时间窗: 3 months
Self-reported completion of low dose chest CT for lung cancer screening during the study follow-up period
次要结局
- Number of Participants with Clinician Discussion on Lung Cancer Screening(3 months)
- Number of Participants with Change in Intent to obtain lung cancer screening(3 months)