A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

Mass General Brigham

Status: Completed

Conditions: Nondaily Smoking

Treatments: Behavioral: Brochure "Clearing the Air" (CTA); Behavioral: Smartphone app "Smiling instead of Smoking" (SiS) Version 3; Behavioral: Smartphone app "QuitGuide" (QG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04672239

2020P003466

Details and patient eligibility

About

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).

Full description

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:

1. 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)
2. Test for differences between randomized groups on secondary outcomes (as listed in Detailed Protocol)
3. (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.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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229 participants in 3 patient groups

Smiling Instead of Smoking (SiS) app

Experimental group

Description:

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.

Treatment:

Behavioral: Smartphone app "Smiling instead of Smoking" (SiS) Version 3

QuitGuide (QG) app

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smartphone app "QuitGuide" (QG)

Clearing the Air (CTA) brochure

Other group

Description:

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.

Treatment:

Behavioral: Brochure "Clearing the Air" (CTA)