A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- number of cigarettes smoked/day
研究概览
简要总结
This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.
In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.
The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.
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详细描述
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This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
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This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:
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ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
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Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
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Participants will be in this research study for up to 6-months.
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It is expected that about 250 people will take part in this research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •55 to 77 years of age
- •No previous history of lung cancer
- •ECOG performance status < 2
- •≥ 30 pack year smoking history
- •Smoke ≥ 5 cigarettes/day
- •Own a mobile phone with access to a video call application
- •Has a primary care provider (PCP)
- •Provide contact information for the PCP
- •Active health insurance
- •Has not had LDCT screening
- •English speaking
- •Can complete an interview
排除标准
- •Hospitalization for severe mental illness within the last year.
- •The following special populations will not be included
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
number of cigarettes smoked/day
时间窗: 6 months
self-report number of cigarettes will be compared with exact Poisson test.
7-day point prevalence smoking cessation rate
时间窗: 6 months
biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,
Lung cancer screening behavior measure
时间窗: 6 months
(stage of low-dose computed tomography \[LDCT\] screening adoption) Lung Cancer Screening Behaviors\[20\] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,
次要结局
- Percentage of the group indicate that the film would have value to others(3 months)
- Completion rate(3 months)
- Polygenic risk score (PRS)(6 months)
- Percentage of the group perceive the film as just right in length(1 month)
- Narrative Engagement Scale scores(3 months)
- Qualitative interviews(6 months)
研究者
Mary E. Cooley, Phd
Principal Investigator
Dana-Farber Cancer Institute