Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 6
- 主要终点
- Number of Participants With Self-reported Past 7-day Smoking Abstinence
研究概览
简要总结
This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.
详细描述
Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- •Scheduled to undergo LDCT-LCS at a participating Mass General Brigham Health Care System LCS site
- •Speak English or Spanish.
- •Current smokers: smoked a cigarette, even a puff, in the last 30 days.
- •Medicare coverage requirement (age 50-80 years, 20+ pack/years).
- •Residing within the USA.
排除标准
- •Undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation.
- •Unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study PI or treating clinician.
- •No access to a telephone or cannot communicate by telephone.
研究组 & 干预措施
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Community Resource (Behavioral)
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Counseling (Behavioral)
Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Nicotine patch (Drug)
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Counseling (Behavioral)
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Nicotine patch (Drug)
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Community Resource (Behavioral)
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Counseling (Behavioral)
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Nicotine patch (Drug)
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
干预措施: Community Resource (Behavioral)
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Counseling (Behavioral)
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Nicotine patch (Drug)
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
干预措施: Community Resource (Behavioral)
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
干预措施: Counseling (Behavioral)
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
干预措施: Nicotine patch (Drug)
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
干预措施: Counseling (Behavioral)
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
干预措施: Nicotine patch (Drug)
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
干预措施: Counseling (Behavioral)
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
干预措施: Nicotine patch (Drug)
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
干预措施: Counseling (Behavioral)
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
Number of Participants With Self-reported Past 7-day Smoking Abstinence
时间窗: 6 Months after enrollment
Number of participants that self-reported no cigarette smoking in the past 7 days
次要结局
- Proportion of Participants Who Reduced the Number of Cigarettes Smoked Per Day in Half(6 months)
- Proportion of Patients Who Make an Intentional Attempt to Quit Smoking(3 months)
- Number of Participants With Self-Reported Past 7-day Smoking Abstinence(3 months after enrollment)
研究者
Elyse Park, PhD
Associate Professor of Psychiatry
Massachusetts General Hospital