1. Single Arm Trial of SmartQuit 2.0 ACT App for Smoking Cessation Jonathan Bricker, PhD Public Health Sciences, Fred Hutchinson Cancer Research Center Psychology Department, University of Washington, Seattle, Washington, USA Public Health Sciences, Fred Hutchinson Cancer Research Center Psychology Department, University of Washington, Seattle, Washington, USA

2. ©2016 Fred Hutchinson Cancer Research Center Disclosures Neither I nor any of my research team has any financial relationships to SmartQuit or are receiving any compensation for this presentation. Fred Hutchinson Cancer Research Center licenses SmartQuit technologies to 2Morrow.

3. ©2016 Fred Hutchinson Cancer Research Center Grant Funding Sources: $14 Million Dollars National Cancer Institute R01-CA-166646 (PI: Bricker) R01-CA-151251 (PI: Bricker) R01-CA-192849 (PI: Bricker) National Institute on Drug Abuse R01-DA-038411 (PI: Bricker) R21-DA-030646 (PI: Bricker) Lee Hartwell Innovation Fund (PI: Bricker) Snoqualmie Tribe (PI: Bricker) Fred Hutch Cancer Research Center Pilot Funding (PI: Bricker) Life Sciences Discovery Fund 12328761 (Site PI: Bricker; PI: Masterson)

4. Core Collaborators & Partners Terry Bush, PhD Alere, Seattle Feng Cheng, PhD Tsinghua University, Beijing Rutger Engels, PhD Trimbos, Netherlands Jaimee Heffner, PhD Fred Hutch, Seattle Julie Kientz, PhD University of Washington, Seattle Jennifer McClure, PhD Group Health, Seattle Robert Whelan, PhD University College, Ireland 2 Morrow Inc. Mobile Health Programming & Sales, Seattle Blink UX Web Design, Seattle Collaborative Data Services Data ops, Fred Hutch Harvard University Health Communications Boston Moby, Web Programming Design & Programming, Seattle Nutrition Assessment Shared Resource Data ops, Fred Hutch ©2016 Fred Hutchinson Cancer Research Center

5. XXXXXXXXXXXX XXXXXXXXXXX ©2016 Fred Hutchinson Cancer Research Center

6. Cigarette Smoking: Most Preventable Cause of Death Worldwide © Fred Hutchinson Cancer Research Center5 6 million deaths/year

7. ©2016 Fred Hutchinson Cancer Research Center

8. Quit Smoking Apps Availability: 500+ available in English (Bricker 2014) Reach: 3.2 million US downloads in the two-year 2012-2013 period (XYO.NET, 2014), and estimated now 2 million annually Effectiveness: None had been tested in RCT…until SmartQuit 1.0 trial

9. First Randomized Trial of Adult Quit Smoking App: SmartQuit 1.0 Trial

10. ©2016 Fred Hutchinson Cancer Research Center

12. SmartQuit Features Name core values inspiring quitting Set a quit date Learn ACT skills to manage urges Encourage medications, including patch, gum, & Chantix

13. ©2016 Fred Hutchinson Cancer Research Center SmartQuit 1.0 Trial CONSORT Diagram Screened: 738 Eligible: 400 Consented: 340 Confirmed by phone: 205 Randomized: 196 Smart Quit: 98Quit Guide: 98 70-day Follow-up: 80 70-day Follow-up: 84

14. ©2016 Fred Hutchinson Cancer Research Center Engagement Quit GuideSmartQuitp-value Number of times opened app15.237.20.0001

15. ©2016 Fred Hutchinson Cancer Research Center 70-Day Follow-up (30-day quit rate) Quit GuideSmartQuitOR (95% CI) 8%13%2.7 (0.8, 10.3)

16. ©2016 Fred Hutchinson Cancer Research Center 70-Day Follow-up (30-day quit) Baseline Subgroups Baseline Subgroup Quit GuideSmartQuitOR (95% CI) At Least Pack-A-Day6%11%1.8 (0.1, 53.3) Avoidant of Cravings8%15%2.9 (0.6, 20.7)

17. ©2016 Fred Hutchinson Cancer Research Center What’s Popular vs. What’s Helpful Content Source Feature# users OR (p) USCGPViewed quit plan overview 7611.1 (.03) USCGPViewed progress in calendar 652.8 (.17) USCGPOpened sharing page 642.5 (.23) USCGPViewed progress in chart 641.7 (.44) ACTTracked acceptance 6110.5 (.03) Most Popular Content Source Feature# users OR (p) ACTTracked ACT skills practice 4316.4 (.01) USCGPViewed quit plan overview 7611.1 (.03) ACTTracked acceptance 6110.5 (.03) ACTViewed Staying Motivated video 154.1 (.06) ACTViewed Handling Urges video 154.1 (.06) Most Helpful (Heffner et al., AJDAB, 2015)

18. ©2016 Fred Hutchinson Cancer Research Center Single Arm Trial of a Quit Smoking App: SmartQuit 2.0 Trial

19. Aim 1: Re-Design Structured program with a certificate of completion focused on features most predictive of quitting: urge tracking and key ACT. Aim 2: Satisfaction And descriptively compare 2.0 with 1.0. Aim 3: Cessation And descriptively compare 2.0 with 1.0. Aim 4: Completion Does completion predict cessation? ©2016 Fred Hutchinson Cancer Research Center Aims

20. ©2016 Fred Hutchinson Cancer Research Center SmartQuit 2.0

21. ©2016 Fred Hutchinson Cancer Research Center SmartQuit 2.0 Trial CONSORT Diagram Screened: 443 Eligible: 347 Consented: 221 Confirmed by email: 161 Smart Quit: 99 70-day Follow-up: 80 70-day Follow-up: 84

22. ©2016 Fred Hutchinson Cancer Research Center Baseline Demographics: SmartQuit 2.0 vs. 1.0 Demographic 2.0 (N=99) 1.0 (N=96) Age, mean (SD) 38 (8.9)41 (12.0) Female88%53% Caucasian97%85% Married40%37% Working70%58% HS or less25%14% Nicotine Dependence (FTND)5.5 (2.1)4.9 (2.5) Smokes at least ½ pack32%28% Smoked 10+ Years81%72% Live with partner who smokes25%24%

23. ©2016 Fred Hutchinson Cancer Research Center Satisfaction: SmartQuit 2.0 vs. 1.0 Satisfaction Indicator 2.01.0 Satisfied Overall84%59% Recommend to Friend73%52% Useful for Quitting74%53%

24. ©2016 Fred Hutchinson Cancer Research Center Cessation & Reduction: 2.0 vs. 1.0 70-Day Follow-up2.01.0 30-Day Quit Rate11% Reduced Smoking75%32%

25. ©2016 Fred Hutchinson Cancer Research Center Cessation in 2.0: All vs. Completers SmartQuit 2.0 30-Day Quit Rate All Participants11% Program Completers (24% of All)28%

26. SmartQuit 2.0 Completion Predicts Cessation Completion Measure Quit Outcome Full Completion of the Program: 24% of AllOR4.45 95% CI1.13, 17.45 p-value0.032 Depth of Completion Number of Quit Plan ViewsOR2.00 95% CI0.92, 4.34 p-value 0.078 Each ACT Module CompletedOR1.27 95% CI1.01, 1.60 p-value 0.042 Each Urge Passed Tracked OR1.02 95% CI1.00, 1.03 p-value 0.043 Number of Anytime Coaching usesOR0.97 95% CI0.87, 1.09 p-value 0.624 (Zeng et al., in review) ©2016 Fred Hutchinson Cancer Research Center

27. Fully Powered Randomized Trial of a Quit Smoking App: SmartQuit 3.0 Randomized Trial Fully Powered Randomized Trial of a Quit Smoking App: SmartQuit 3.0 Randomized Trial

28. ©2016 Fred Hutchinson Cancer Research Center SmartQuit 3.0 Trial $3.1 Million US Dollars, Funded by National Cancer Institute Year 1: Design & develop SmartQuit 3.0 by synthesizing trial and user research from SmartQuit 2.0. Years 2-4: -Conduct trial of 1622 nationally-recruited adult smokers -Randomize to SmartQuit or NCI’s Quit Guide -3, 6, & 12 Month Follow-up Year 5: Analyze, publish, and disseminate results

29. ©2016 Fred Hutchinson Cancer Research Center SmartQuit 3.0 Design User Testing

30. ©2016 Fred Hutchinson Cancer Research Center Summary SmartQuit 2.0 advances smoking cessation app technology through a structured program with research-driven features that predict quit rates. In the challenging higher female & less educated sample with longer smoking history, SmartQuit 2.0 had: 1. High user satisfaction 2. Modest quit rates 3. High reduction in smoking Program completion may be key to boosting quit rates.

31. Thank you Dr. Jonathan Bricker jbricker@fredhutch.org