Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
3-group proof-of-concept RCT
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SiS
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.
  • Behavioral: Smartphone app "Smiling instead of Smoking" (SiS) Version 3
    Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
    Other names:
    • SiS
Active Comparator
QG
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.
  • Behavioral: Smartphone app "QuitGuide" (QG)
    Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
    Other names:
    • QG
Other
CTA
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.
  • Behavioral: Brochure "Clearing the Air" (CTA)
    Participants will be onboarded to the brochure "Clearing the Air" and will be asked to use it for 7 weeks to support them in quitting smoking.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kaitlyn Siegel
617-724-3129
QNS@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Kaitlyn Siegel
617-724-3129
sis@mgh.harvard.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.