Condition category
Mental and Behavioural Disorders
Date applied
26/04/2018
Date assigned
17/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
In Switzerland, lung cancer is the first cause of cancer death, and in women, lung cancer will soon surpass breast cancer as the first cause of cancer death. Thus, effective smoking cessation interventions are necessary, and these interventions need to be widely disseminated. Smartphone-based support can reach thousands of smokers and have a substantial public health impact, in particular in the majority of smokers who would otherwise try to quit by themselves, without help and with little chance of success. The Stop-tabac fully-automated application (app) for smartphones was launched in 2012 and is now mature and ready for a test of its efficacy. It was ranked among the best five smoking cessation apps worldwide in a recent academic review. The services available on this app include: immediate feedback during episodes of craving and tobacco withdrawal symptoms; an interactive “coach” that provides individually-tailored counseling messages based on responses to a questionnaire (personal profile); a discussion forum (“The Tribe”) where participants receive support from other users; fact sheets; a calculator of cigarettes not smoked, money saved, and years of life gained; and a module on nicotine replacement therapy that includes personalized feedback. The aims of this study are to assess whether this app is effective for smoking cessation, to measure the size of its effect, and to examine whether the outcome is influenced by the personal characteristics of the participants.

Who can participate?
Daily cigarette smokers aged over 18

What does the study involve?
Participants are randomly allocated to either use the Stop-tabac app for 6 months or to use a placebo (dummy) app. Participants are followed up after 1 week, 1 month and 6 months to ask whether they have stopped smoking.

What are the possible benefits and risks of participating?
Participants will not be paid. They will have a chance of accessing a comprehensive smoking cessation app for smartphones, and they will contribute to the science on this topic. There is no risk associated with the behavioral program and the data collection procedure. There is a risk that data may be accessed by hackers. The researchers will make every effort to minimize this risk by using appropriate security measures.

Where is the study run from?
ISG - Faculty of Medicine - University of Geneva (Switzerland)

When is the study starting and how long is it expected to run for?
December 2016 to December 2021

Who is funding the study?
Swiss National Science Foundation

Who is the main contact?
Prof. Jean-François Etter

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-François Etter

ORCID ID

http://orcid.org/0000-0002-1426-3157

Contact details

ISG-Campus Biotech
9 ch. des Mines
Geneva
1202
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SNF 320030_179369

Study information

Scientific title

Impact of a smartphone application on smoking cessation: a randomized controlled trial

Acronym

Study hypothesis

An application for smartphone will help smokers stop smoking.

Ethics approval

Not provided at time of registration

Study design

Two-arm parallel-group individually randomized “placebo”-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cigarette smoking

Intervention

The trialists will randomly assign 5200 smokers to either using the Stop-tabac application for smartphones for 6 months or to use a placebo application. Stop-tabac is a fully-automated application (“app”) for smartphones that includes:
1. Immediate feedback during episodes of craving and tobacco withdrawal symptoms
2. An interactive “coach” that provides individually-tailored counseling messages based on responses to a questionnaire (personal profile). These automated messages are sent regularly during 6 months
3. A discussion forum (“The Tribe”) where participants receive support from other users
4. Fact sheets; a calculator of cigarettes not smoked, money saved, and years of life gained
5. A module on nicotine replacement therapy that includes personalized feedback
Follow-up after 1 week, 1 month and 6 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Self-reported smoking cessation at 6 months (no puff of tobacco in the past 4 weeks). All data will be self-reported via online questionnaires. Participants can use any device to answer (smartphone, tablet, laptop, desktop). There will be no biochemical validation of smoking status. Assessed 4 times: at baseline, and 1 week, 1 month and 6 months after the participant’s target smoking cessation date.

Secondary outcome measures

1. Point prevalence of smoking abstinence at 6 months (no puff of tobacco in the previous 7 days)
2. Russell Standard (<5 cigarettes in the past 6 months plus no puff of tobacco in the past 7 days)
3. Abstinence of any tobacco and e-cigarette use at 6 months (no use in the previous 7 days)
4. Motivation to quit
5. Quit attempts (number and duration)
6. Confidence in ability to quit
7. Use of nicotine therapy
8. Use of e cigarettes and heated tobacco products

All data will be self-reported via online questionnaires. Participants can use any device to answer (smartphone, tablet, laptop, desktop). There will be no biochemical validation of smoking status. Assessed 4 times: at baseline, and 1 week, 1 month and 6 months after the participant’s target smoking cessation date.

Overall trial start date

01/12/2016

Overall trial end date

01/12/2021

Reason abandoned

Eligibility

Participant inclusion criteria

1. Daily cigarette smoker
2. Has been a daily smoker for at least one year
3. >18 years old
4. Sets a target quit date within one month of enrollment and commits to quit on this date
5. Provides informed consent online
6. Commits to answer all follow-up questionnaires, and commits to use the app
7. Owns a smartphone with Android operating system and has regular access to the Internet
8. Provides a postal address and telephone number, and a valid e-mail address
9. Lives in Switzerland or in France

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

5200

Participant exclusion criteria

Prior use of the Stop-tabac app for smartphones (self-report)

Recruitment start date

01/09/2018

Recruitment end date

01/09/2021

Locations

Countries of recruitment

Switzerland

Trial participating centre

ISG - Faculty of Medicine - University of Geneva
9 chemin des Mines Campus Biotech
Geneva
1202
Switzerland

Sponsor information

Organisation

University of Geneva

Sponsor details

ISG-Campus Biotech
9 ch. des Mines
Geneva
1202
Switzerland

Sponsor type

University/education

Website

https://www.unige.ch

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

The trialists plan to publish the study protocol in a peer-reviewed journal. The results will be published in a peer-reviewed scientific journal and presented at an international conference.

IPD sharing statement
A data management plan was submitted and accepted by the Swiss National Science Foundation, which supports this project. The shared SPSS data file, with participant-level data, will be fully documented, which means that the variable labels and value labels will include the full wording of questions and of response options.
An accompanying README.TXT file will include:
1. An explanation of how and when the data were collected and prepared
2. The names and addresses of the investigators
3. The conditions required to access the data
4. A description of the original study and of the data collection methodology
5. Additional information about how the data were collected, processed and analyzed, giving more technical details than in the publications
6. The SPSS syntax used to transform variables
7. A list of the publications based on these data
The trialists will deposit the participant-level data, with sufficient accompanying metadata and information, on the future repository of Swiss Universities (DLCM project), that will most certainly be available when the study
ends (https://scicore.unibas.ch/projects/dlcm/). If the DLCM project does not materialize, the trialists will archive the data in the ZENODO repository (https://zenodo.org/). The data file will be identified by a DOI. The data will be made available after the publication of the main article describing the study’s results. In the final shared data file, the data will be anonymous, and any indication allowing the identification of study participants will be deleted (names, addresses, e-mails, phone numbers). There will be no possibility to track the identity of study participants. As required by Swiss law, the study will be approved by the ethics committee of the canton of Geneva. This approval will include the data collection, storage and sharing procedures. Study participants will be informed that their responses to the questionnaires will be made publicly available in an anonymous format. This will be included in the informed consent form.

Intention to publish date

31/12/2021

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes