Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000990729
Ethics application status
Approved
Date submitted
13/06/2022
Date registered
14/07/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Screen2Quit: An electronic smoking cessation resource for smokers undergoing lung cancer screening.
Scientific title
A randomised controlled trial assessing the effect of the electronic smoking cessation resource Screen2Quit on the self-reported and biochemically verified quit rate in smokers undergoing lung cancer screening
Secondary ID [1] 303178 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12619000159156 was the pilot randomised controlled trial of electronic smoking cessation resources for smokers undergoing lung cancer screening.

Health condition
Health condition(s) or problem(s) studied:
nicotine addiction 320306 0
Lung cancer screening 326676 0
Condition category
Condition code
Mental Health 318225 318225 0 0
Addiction
Public Health 318226 318226 0 0
Health promotion/education
Respiratory 318227 318227 0 0
Other respiratory disorders / diseases
Cancer 323915 323915 0 0
Lung - Non small cell
Cancer 323916 323916 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants undergoing lung cancer screening will be invited to participate in a smoking cessation study via an online survey where they will be assessed for eligibility. When randomised to the intervention, a personalised link to the purpose built research version of the publicly available smoking cessation smart-phone app (My QuitBuddy renamed Screen2Quit) will be sent to the participant's own mobile phone for them to download. The app will be used ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). My Screen2Quit usage will be determined by patient questionnaires for twelve months following randomisation and the collection of "back end" data analytics. Screen2Quit is an app personalised to help people quit smoking using educational and motivational tools. Users enter their planned quit date, smoking history, and set goals for quitting smoking. The app sends daily reminders and provides daily updates on health benefits of quitting, money saved, can be tailored to interact with the participant at self identified "danger times" for smoking.
Intervention code [1] 319487 0
Treatment: Other
Intervention code [2] 323794 0
Treatment: Devices
Comparator / control treatment
Participants will be directed to a tailored smoking cessation resources web page subsequent to jurisdiction (e.g Queensland participants will be directed to (https://quithq.initiatives.qld.gov.au/). This resource is to be used ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating team (e.g. Quitline counselling, pharmacotherapy). Web page usage will be determined by participant questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 326209 0
Self-reported smoking abstinence via questionnaire
Timepoint [1] 326209 0
3 months (primary endpoint) and 12 months post randomisation
Primary outcome [2] 326210 0
Biochemically verified continuous abstinence will be determined using Cotinine measured in urine, or saliva.
Timepoint [2] 326210 0
Biochemically verified continuous abstinence will be measured at 3 months and 12 post randomisation.
Primary outcome [3] 331993 0
Self reported smoking abstinence via questionnaire
Timepoint [3] 331993 0
12 months post randomisation (primary endpoint)
Secondary outcome [1] 390520 0
Uptake, use and acceptability of smartphone app (via the user Mobile App Rating Scale - uMARS)
Timepoint [1] 390520 0
2 weeks, 3 months, 6 months and 12 months post randomisation for those who have interacted with their allocated eResource (app or webpage). The follow up at 2 weeks is to determine if participants have accessed the allocated eResource in the early stages of the study, this is the only information collected at the 2 week time point.
Secondary outcome [2] 390522 0
Use of counselling (participant questionnaire designed specifically for this study)
Timepoint [2] 390522 0
3, 6 and 12 months post randomisation
Secondary outcome [3] 390523 0
Quit attempts,(participant questionnaire designed specifically for this study)
Timepoint [3] 390523 0
3, 6 and 12 months post randomisation
Secondary outcome [4] 390524 0
Change in motivation score (participant questionnaire designed for this study)
Timepoint [4] 390524 0
3, 6 and 12 months post randomisation
Secondary outcome [5] 410874 0
Use of pharmacotherapy assessed via questionnaire designed specifically for this study
Timepoint [5] 410874 0
3, 6 and 12 months post randomisation

Eligibility
Key inclusion criteria
Adults smokers who are eligible for lung cancer screening and are able to give informed consent, own a smartphone and a computer, are capable of downloading an app and have access to the internet
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who do not own a smartphone and/or do not have access to the internet. Smokers who are current users of a smoking cessation smartphone app.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done centrally using a computer generated random numbers stratified by hospital site and grouped in block of 6. The randomisation sequence has been generated by a biostatistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
13/07/2023
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
690
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 18417 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 18418 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 18419 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 18420 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [5] 18421 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 18422 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 32524 0
4032 - Chermside
Recruitment postcode(s) [2] 32525 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 32526 0
3050 - Parkville
Recruitment postcode(s) [4] 32527 0
3128 - Box Hill
Recruitment postcode(s) [5] 32528 0
6009 - Nedlands
Recruitment postcode(s) [6] 32529 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 23386 0
Canada
State/province [1] 23386 0
British Columbia

Funding & Sponsors
Funding source category [1] 307587 0
Government body
Name [1] 307587 0
National Health and Medical Research Council
Country [1] 307587 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 308278 0
None
Name [1] 308278 0
Address [1] 308278 0
Country [1] 308278 0
Other collaborator category [1] 281853 0
Hospital
Name [1] 281853 0
The Prince Charles Hospital
Address [1] 281853 0
Level 2, Admin Building
Rode Rd
Chermside, Qld, 4032
Country [1] 281853 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307642 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 307642 0
Building 14
Rode Rd
Chermside Qld 4032
Ethics committee country [1] 307642 0
Australia
Date submitted for ethics approval [1] 307642 0
10/12/2020
Approval date [1] 307642 0
29/01/2021
Ethics approval number [1] 307642 0
HREC/2021/QPCH/70317

Summary
Brief summary
The goal of this study is to undertake rigorous scientific evaluation of the most popular Australian high-quality smoking cessation app. Screen2Quit (formally known as My QuitBuddy) in current smokers scheduled to undergo lung cancer screening.
Who is it for?
You may be eligible for this study if you are aged 55 years and over, you currently smoke, and you are eligible for lung cancer screening.
Study details
Participants will be randomised (i.e. allocated by chance) to either receive access to the Screen2Quit app, or will be directed to a tailored smoking cessation resources webpage. Participants in the Screen2Quit group will be sent a link to download the app to their phone, through which users may enter their planned quit date, smoking history, and set goals for quitting smoking. The app sends daily reminders and provides daily updates on health benefits of quitting, money saved, can be tailored to interact with the participant at self-identified "danger times" for smoking. Each participant’s use of the app will be determined through questionnaires and by accessing app analytics. Participants who do not receive access to the app will be directed to an online resource according to their jurisdiction (e.g. Queensland participants will be directed to the Qld government smoking cessation website QuitHQ). Participants will be instructed to use the app/web page resources ad lib in conjunction with whichever standard smoking cessation therapies are recommended by their treating health team (e.g. Quitline counselling, pharmacotherapy). All participants will be followed-up for 12 months post-enrolment to assess their self-reported quit rate, biochemically verified abstinence from smoking using a urine test, quit attempts, motivation, and use of counselling/pharmacotherapy.

It is hoped that this study may show that the Screen2Quit app, when used with usual care, increases quit rates compared to usual care alone in smokers undergoing lung cancer screening.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107974 0
A/Prof Henry Marshall
Address 107974 0
The Prince Charles Hospital
Level 2, Admin building
Rode Rd, Chermside, Qld, 4032
Country 107974 0
Australia
Phone 107974 0
+61 731396805
Fax 107974 0
Email 107974 0
[email protected]
Contact person for public queries
Name 107975 0
Ms Jenny Peek
Address 107975 0
The Prince Charles Hospital
Level 2, Admin building
Rode Rd, Chermside, Qld 4032
Country 107975 0
Australia
Phone 107975 0
+61 731396802
Fax 107975 0
Email 107975 0
[email protected]
Contact person for scientific queries
Name 107976 0
Ms Jenny Peek
Address 107976 0
The Prince Charles Hospital
Level 2, Admin building
Rode Rd, Chermside, Qld 4032
Country 107976 0
Australia
Phone 107976 0
+61 731396802
Fax 107976 0
Email 107976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Complete de-identified patient data set
When will data be available (start and end dates)?
Available for 5 years after publication
Available to whom?
Teams with requisite expertise and HREC approved protocols
Available for what types of analyses?
Any that have received HREC approval
How or where can data be obtained?
Electronic transfer when requested directly to the Principal Investigator via email:
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.