A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
研究概览
简要总结
This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 - 6/30/2021). Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. The present study is Study 3. It is a 3-group proof-of-concept RCT, in which we seek to test if our app (i.e., Version 3 of our developed smartphone app, called 'Smiling instead of Smoking' (SiS)) is superior to treatment as usual (i.e., TAU) and superior to a control app (i.e., the National Cancer Institute's smartphone app "QuitGuide" (QG).
详细描述
This is a nation-wide proof-of-concept randomized controlled trial conducted entirely remotely. Participation will last 6 months and entails:
- Completing a scripted onboarding call (approximately 30-45 minutes)
- Making a quit attempt
- Engaging with smoking cessation support (randomized) over the course of seven weeks, one week prior and 6 weeks following the originally chosen quit day
- Completing five online, REDCap-administered surveys, administered prior to the quit day (online, as part of a screening test), and at 2-week, 6-week, 3-month, and 6-month follow-ups of the participant's chosen quit day
The Aims of the study are:
- Test for differences between randomized groups on the primary outcome (i.e., self-efficacy to remain abstinent, as measured via the Smoking Self-Efficacy Questionnaire), as measured at end of treatment (i.e., 6 weeks after the participants' chosen smoking quit day)
- Test for differences between randomized groups on secondary outcomes (as listed in Detailed Protocol)
- (exploratory) To test, via mediational modeling, how treatment via the proposed app conferred benefit; or, if not effective, if failure is due to the treatment failing to impact hypothesized mechanisms of change, or because these mechanisms fail to impact outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18+ years of age
- •smartphone ownership (Android or iPhone only)
- •current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days
- •lifetime history of having smoked 100+ cigarettes
- •willing to make a smoking quit attempt
- •currently residing in the United States of America
排除标准
- •Under 18 years of age
- •Does not own an Android or iPhone
- •Is not a nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days
- •Does not have a lifetime history of having smoked 100+ cigarettes
- •Is not willing to make a smoking quit attempt
- •Is not currently residing in the United States of America
研究组 & 干预措施
Smiling Instead of Smoking (SiS) app
Participants will be onboarded (remotely) to the smartphone app "Smiling instead of Smoking" (SiS), and will be asked to use it for 7 weeks while they quit smoking.
干预措施: Smartphone app "Smiling instead of Smoking" (SiS) Version 3 (Behavioral)
QuitGuide (QG) app
Participants will be onboarded (remotely) to the smartphone app "QuitGuide" (QG), and will be asked to use it for 7 weeks while they quit smoking.
干预措施: Smartphone app "QuitGuide" (QG) (Behavioral)
Clearing the Air (CTA) brochure
Participants will be onboarded (remotely) to the NCI brochure "Clearing the Air" (CTA), and will be asked to use it for 7 weeks while they quit smoking.
干预措施: Brochure "Clearing the Air" (CTA) (Behavioral)
结局指标
主要结局
End of Treatment Group Differences in Smoking Self-Efficacy Questionnaire (SEQ)
时间窗: Up to 24 weeks post quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (baseline = week -1).
The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, \& Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking.
次要结局
- Self-reported 30-day Point-prevalence Abstinence(Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Self-reported Past Week Cigarette Change(Assessed at 2, 6, 12, and 24 weeks post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Satisfaction With Smoking Cessation Support(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Time Spent Applying Content Brought up by the Apps/"Clearing the Air"(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Use of Smoking Cessation Strategies(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Perceived Impact of the Provided Materials on Quitting(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Appreciation(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Actual App Usage (SiS and QG Only)(Cumulative from week 0 to week 24 post-quit day. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Self-reported App Usage, Weeks 3 to 6 Post-quit (SiS and QG Only)(From week 3 to week 6 post-quit. Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Likability Rating of the App (SiS and QG Only)(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- Satisfaction Rating of the Smoking Cessation Support (SiS and QG Only)(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
- App Usability Ratings (SiS and QG Only)(Assessed at treatment end (week 6 post-quit). Note that the 7 weeks of treatment started 1 week prior to the quit date (i.e., baseline = week -1).)
研究者
Bettina B. Hoeppner
Associate Professor
Massachusetts General Hospital