Personalized Smoking Cessation Tool Based on Patient Lung CT Image
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- Report's Impact on Calling a Quitline Number
研究概览
简要总结
Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's effectiveness at motivating smokers to call a Quitline.
详细描述
Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by calling a Quitline, and (b) the effectiveness of a 45-minute telephone smoking cessation counseling session for motivating an actual quit attempt and abstinence. The RCT will enroll approximately 400 randomly selected participants from lung screening programs at HealthPartners and University of Michigan. Participants will be randomly assigned to one of four conditions: 1) Usual Care + quitline phone number (created specifically for the trial and maintained for the length of the trial); 2) Usual Care + Report (Report will list Quitline number) 3) Usual Care + Counseling, or 4) Usual Care + Report + Counseling. Follow up assessment calls will be conducted with participants at three weeks, three months, and six months following the mailing of the report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
University of Minnesota Office of Measurements Services will administer follow up calls to assess outcomes. Callers will be blinded to the arm to which the patients were assigned.
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
- •30-pack year smoking history
- •currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan
排除标准
- •current use of smoking cessation medications
- •scan read as a category 3, 4A, 4B or 4X in Lung-RADS
- •unstable medical or psychiatric conditions
- •current alcohol or drug use disorder
- •past-month suicidal ideation
- •past-year suicide attempt
结局指标
主要结局
Report's Impact on Calling a Quitline Number
时间窗: 6 months after intervention
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
时间窗: 6 months after intervention
This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking? Answer options include: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
次要结局
未报告次要终点