Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000820707
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
10/06/2022
Date last updated
19/04/2023
Date data sharing statement initially provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Quit by Phone Study: A telephone-based smoking cessation study among low-socioeconomic status smokers in Australia
Scientific title
Tailored Text Messaging versus standard Quitline services for smoking cessation among low-socioeconomic status Australian smokers: a non-inferiority trial
Secondary ID [1] 307180 0
None
Universal Trial Number (UTN)
U1111-1261-0274
Trial acronym
QPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking 326397 0
Condition category
Condition code
Public Health 323684 323684 0 0
Health service research
Mental Health 323685 323685 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant randomised to the Tailored Text Message (TTM) group will receive 12 months of text message-based quit support, that will commence immediately after baseline interview completion. The intensity of TTM smoking cessation support will be high in the first few weeks prior to- and following participants’ quit attempt, after which the frequency of text message support will taper. The provision of 12 months of interactive and tailored support ensures low-SES smokers have every chance of success.
The TTM program will be developed from the successful STOMP mCessation programme, and utilise and build upon existing text messages adopted in a current ANZCTR registered clinical trial (ACTRN12621000076875), with further refinement to ensure it meets the needs of Australian low-SES smokers. The program will be implemented based on the World Health Organization’s (WHO) mTobaccoCessation handbook and key guidelines including: (i) a needs assessment,(ii) establishing a technical advisory group, (iii) conducting formative consumer advisory research, (iv) text message program and algorithm development, (v) technology specification (building upon the STOMP mCessation programme), (vi) recruitment, and (vii) monitoring and evaluation.

Text message content will be based on behaviour change techniques (BCTs) and related taxonomy, which will help ensure rigorous and replicable characterisation of the program’s active components. Tailoring of some text messages will occur based on participants’ demographic and other information gathered at enrollment (e.g., name, smoking habits). At first, text messages will be focused on preparing participants to quit smoking. Participants at enrollment will be instructed that their quit date will be 8 days from enrollment and to aim abstain from smoking. Once quit, the focus of the messages will shift to preventing relapse with an emphasis on achieving milestones over time. Messages will be sent at scheduled time intervals, with pivotal texts to be sent around the quit date and in the first two weeks after the quit date. Participants can access text message support at any time regardless of scheduled time intervals, through the on-demand keyword function explained below.

The TTM program will cater to an iterative quitting process by means of an on-demand keyword function that will allow interactive bi-directional text message interactions between the program and its users. For example, texting the word “CRAVE” will provide instant advice on how to cope with cravings, and the words “LAPSE” or “SLIP” will provide instant support to encourage continuation of the quit attempt. By texting “COMMIT”, participants can pledge their commitment to staying quit and smoke free. The “PAUSE” function can be used to put the text message program on hold, which can then be resumed later via a “RESUME” function. Participants will have the opportunity to opt-out of the program at any time, through the “STOP” function, and will still be able to continue study participation. The TTM program will have the capability to detect synonyms and street slang for keywords, and will be enhanced to address comorbidities including mental health by ensuring stress, anxiety, depression and other associated urges and behaviours are addressed using real-time interactive data. For instance, the “STRESS” command will offer advice on how to plan for- and manage stress associated with quitting, “BORED” will provide tips on how to deal with boredom, while the word “SOCIAL” will encourage and support perseverance in the quit attempt. Following their randomisation to the TTM group, participants will be texted a list of keywords that they can use for this bi-directional interactive function. Participants will also be provided with a wallet card listing the keywords and their functions.

Participants will receive a mix of behavioural quit support text messages covering the following content:
• coping with tobacco withdrawal symptoms;
• study progress updates;
• goals and planning;
• relapse prevention; and
• motivational ‘feel good’ messages

Text messages will include text, emojis, and hyperlinks to web-based videos, quit support websites and graphics interchange format (GIF) images, to promote engagement with the program. The program will incorporate a ‘Quit Buddy’ persona named Lou, introduced on the first day of the program (‘Hi, my name is Lou and I will be your quit buddy. Let’s help you quit, one day at a time!’). Similar to Quitline telephone support, the TTM program will offer advice on available smoking cessation treatments and encourage the use of pharmacotherapy treatment.

The text message program will last for a duration of 12 months. The program will start the day after randomisation. Texts are sent at a random time between a designated time window and will be scheduled as follows;

- 3 texts per day (text 1 between 9am and 11am, text 2 between 12pm and 2pm, text 3 between 5pm and 7pm) for month 1

- 2 texts per day (text 1 between 9am and 11am, text 2 between 3pm and 5pm) for month 2

- 1 text per day (each day the text is sent in a different time window. Eg., day 65 between 9am and 11am, day 66 between 12pm and 2pm) for months 3 – 5

- 2 texts per week (first text of the week on a Tuesday morning between 9am and 11am, second text on a Friday evening between 5pm and 7pm) for months 6 – 12

Texts will be scheduled and sent automatically using a third-party provider, based in Sydney, Australia. Every text reply from participants will be sent directly to the Quit by Phone Study email to monitor for any issue.

The Quit by Phone Study Research Team will download daily reports of replied messages to monitor the use of the keyword function. Participants who have changed their status to ‘paused’ or ‘stopped’ will be recorded in a status report. Each participant's tailored text message sequence is automatically populated into the text delivery software and follows the above date and time stamp for delivery. Furthermore, we will perform daily downloads of all activity in the text message program to ensure all messages have been sent and delivered. Additionally, we will perform weekly spot checks of participants scheduled messages to ensure the tailoring function is working optimally.
Intervention code [1] 323631 0
Behaviour
Intervention code [2] 323756 0
Lifestyle
Comparator / control treatment
Each participant randomised to the standard Quitline (SQ) group will be referred to the NSW Quitline (13 7848, or, 13 QUIT); a confidential telephone service designed to help smokers quit and maintain abstinence from tobacco smoking. The NSW Quitline telephone service works with smokers in various ways to help (i) develop a quit plan, (ii) discuss strategies for managing withdrawals and cravings, (iii) manage setbacks, (iv) offer advice on available products to assist with quitting, and (v) recommend local support services. Following their initial call with the NSW Quitline, smokers can request to join the ‘call-back service’, free of charge, through which they may up to schedule six additional telephone support calls from a Quitline Advisor – a qualified professional with specialist training in smoking cessation. These telephone support calls are tailored to the needs of the individual caller (e.g., thinking about quitting and in need of discussion with a NSW Advisor, or ready to quit and in need of a quit plan), and are delivered at a frequency (e.g., weekly, fortnightly, etc.) that is agreed upon based on the individual’s needs. Additionally, callers can request a ‘Quit Kit’, which contains resources to prepare a quit plan, stay quit, manage setbacks, and additional quit support services (e.g., Quit courses, iCanQuit website resources). Participants will be free to opt-out from receiving further Quitline behavioural quit support at any stage and will still be able to continue study participation.
Control group
Active

Outcomes
Primary outcome [1] 331438 0
The primary outcome measure will be biochemically verified 6-month continuous abstinence, recorded at the final 12-month follow-up interview. Continuous 6-month abstinence will be defined as having remained quit (smoked less than or equal to 5 cigarettes) for the entire 6-month period prior to the final follow-up interview. Only participants that self-report continuous 6-month abstinence from tobacco smoking at final follow-up will be asked to complete a biochemical verification test comprising of a carbon monoxide (CO) breath test. These participants will be asked to either (i) attend the TCC or (ii) have a trained research assistant attend their homes or another place specified by the participant to conduct the test, or, (iii) perform the test themselves using a hand-held remote iCO™ Smokerlyzer ® device mailed to them along with accompanying instructions. Participants will be reimbursed $50, either by direct bank transfer or by electronic GiftPay gift card, for their time completing the CO test.

The CO level in the exhaled air will be measured using a hand-held instrument (’Smokerlyzer’). Participants will be requested to inhale and hold their breath for 15 seconds before exhaling into the analyser. A participant with an exhaled CO level of less than or equal to 5 ppm will be considered abstinent.
Timepoint [1] 331438 0
Recorded at the final 12-month follow-up telephone interview
Secondary outcome [1] 409881 0
Self-reported abstinence: defined as self-report of smoking not more than five cigarettes.
Timepoint [1] 409881 0
Recorded at the final 12-month follow-up telephone interview
Secondary outcome [2] 409884 0
Self-reported seven-day point prevalence: (not smoking even a puff in the past 7 days).
Timepoint [2] 409884 0
Assessed at check-in call (15-28 days post randomisation); 3-month online evaluation survey and final 12-month follow-up telephone interview.
Secondary outcome [3] 409885 0
Cigarette consumption among continuing smokers (Number of cigarettes smoked per day; mean reduction and proportion of participants that achieved greater-than-or-equal-to 50% reduction of baseline cigarette consumption) at twelve-month follow-up.
Timepoint [3] 409885 0
Recorded at baseline interview and the final 12-month follow-up telephone interview
Secondary outcome [4] 410607 0
Acceptance and maintenance rate of the intervention (TTM Group). This will be measured at 3 months post baseline via questionnaire items specifically developed for the trial specific interventions.
Timepoint [4] 410607 0
Measured at 3 months post baseline via questionnaire.
Secondary outcome [5] 410608 0
Acceptance and maintenance rate of the active control (SQ Group). This will be measured at 3 months post baseline via questionnaire items specifically developed for the trial specific interventions.
Timepoint [5] 410608 0
Measured at 3 months post baseline via questionnaire.

Eligibility
Key inclusion criteria
Participants can be included if they meet the following criteria:
• aged 18 or over;
• in receipt of a government pension or allowance (proxy for low-SES)*;
• current daily smoker** wanting to quit tobacco smoking;
• able to understand and communicate in English;
• willing and interested to make a quit attempt in the next week;
• own a mobile phone that can receive and send text messages;
• agree to use the allocated behavioural quit support service (TTM or SQ);
• able to provide informed consent

* Low-SES smokers are a diverse group, but receipt of a pension or allowance is an excellent marker for disadvantage because recipients must satisfy a Government’s means-test.
** Tobacco smoker defined as person using any combustible tobacco-containing product
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria for this study.

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)
The data management system (REDcap) at the trial coordinating centre (TCC) will assign a unique randomisation number to study participants using a computer pre-generated randomisation list embedded in the system. To conceal the allocation from those at the TCC responsible for assigning participants, only an external statistician will have access to the pre-generated randomisation list and upload into REDcap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the baseline interview, the data collection system at the TCC will randomly assign each participant to one of the treatment groups in a 1:1 ratio. The permuted block randomisation will use unequal block sizes of 12 and 16.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
A parallel, two-group, single-blind, randomised controlled non-inferiority trial with a non-inferiority margin set at 2% (i.e., the quit rate in the TTM intervention group will be no worse than 2% less than the quit rate in the control SQ group).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a one-sided significance level of 2.5%, a sample size of 1,246 participants (623 participants per group) will confer 90% power to test whether TTM is non-inferior to SQ by a non-inferiority margin of 2% (i.e., the quit rate in the TTM group will be no worse than 2% less than the quit rate in the control (SQ) group).

Baseline characteristics of both study groups will be presented using frequency and percentages for categorical variables and mean and standard deviations or median ± inter quartile range for continuous measures. The primary analysis will compare the quit rates between study groups (p_TTM "and" p_SQ) in a Bayesian framework. Beta-binomial posterior distributions will be generated for each group, using an uninformative beta prior and the observed data for the binomial likelihood. One million random draws from each posterior distribution will be taken, and non-inferiority will be established if 97.5% of these draws support the non-inferiority hypothesis (i.e., Pr(p_TTM-p_SQ>-2%)=0.975). This is equivalent to the lower bound of the 95% credible interval for the difference in quit rates (p_TTM-p_SQ) remaining above the non-inferiority margin (of -2%). The primary analysis will be based on the intention-to-treat principle, where individuals with missing biochemically verified abstinence data will be assumed ‘treatment failures’. Sensitivity analyses will involve: (i) using multiple imputation to account for missing data, including an imputation favoring inferiority of TTM; (ii) excluding participants with missing data; (iii) using informative beta conjugate priors based on previous literature; (iv) use of other smoking cessation medication and/or methods; and (v) excluding participants with protocol deviations.
Superiority of TTM will be established if the Bayesian analysis outlined previously satisfies Pr(p_TTM-p_SQ>0)=0.975, equivalent to the lower bound of the 95% credible interval for the difference in quit rates being greater than 0%.
Secondary analyses will involve comparing secondary outcome measures between study groups using multiple logistic regression. For the secondary cessation outcomes measured at each follow-up, generalized linear mixed models will be used, including time as a fixed effect as well as random effects to adjust for the correlation of observations among individuals over time. All secondary and safety analyses will be conducted under a superiority testing framework and are only to be considered as exploratory analyses. As such, two-sided 95% confidence intervals and p-values will be used to summarise treatment group comparisons, with no adjustment to the type I error rate for multiple comparisons.

The consistency of effects for the primary outcome will be assessed in the following subgroups: age (19-34 years, >34 years), sex (male, female) and nicotine addiction.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
4/11/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
4/10/2024
Actual
Sample size
Target
1246
Accrual to date
619
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311483 0
Government body
Name [1] 311483 0
National Health and Medical Research Council
Country [1] 311483 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 312881 0
None
Name [1] 312881 0
Not Applicable
Address [1] 312881 0
Not Applicable
Country [1] 312881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310946 0
UNSW HREC
Ethics committee address [1] 310946 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 310946 0
Australia
Date submitted for ethics approval [1] 310946 0
24/05/2021
Approval date [1] 310946 0
16/07/2021
Ethics approval number [1] 310946 0
HC210410

Summary
Brief summary
The Quit by Phone Study (QPS) is parallel, two-group, single-blind, randomised controlled non-inferiority trial with an aim of determining, in a low socioeconomic population of smokers, the effectiveness and cost effectiveness of a tailored text message (TTM) program at achieving 6-month continuous biochemically validated smoking abstinence rates, compared to standard Quitline support services (SQ). Secondary outcomes include self-reported abstinence, reduction in number of cigarettes between baseline and follow up, and the acceptance and maintenance rate of each intervention.

The QPS aims to recruit 1246 participants from NSW that are at least 18 years of age; in receipt of a government pension or allowance (proxy for low-SES); current daily smoker wanting to quit tobacco smoking; willing and interested to make a quit attempt in the next week; own a mobile phone that can receive and send text messages; agree to use the allocated behavioural quit support service (TTM or SQ).

The primary analysis is based on intention-to-treat and will compare the quit rates between groups (TTM "and" SQ) in a Bayesian framework. Participants lost to follow-up or not providing biochemical verification result or participants with a CO level > 5 ppm will be included as non-abstainers (smokers).
Trial website
TBC
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119454 0
Dr Ryan Courtney
Address 119454 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 119454 0
Australia
Phone 119454 0
+61 2 9065 7655
Fax 119454 0
Email 119454 0
[email protected]
Contact person for public queries
Name 119455 0
Dr Ryan Courtney
Address 119455 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 119455 0
Australia
Phone 119455 0
+61 2 9065 7655
Fax 119455 0
Email 119455 0
[email protected]
Contact person for scientific queries
Name 119456 0
Dr Ryan Courtney
Address 119456 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 119456 0
Australia
Phone 119456 0
+61 2 9065 7655
Fax 119456 0
Email 119456 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?
We plan to share fully anonymised individual participant data (IPD). All de-identified data of primary and secondary outcomes will be shared, excluding identifiable personal information (i.e., address details, contact information/details) and any relevant SAE/AE information.
When will data be available (start and end dates)?
Following publication, no end date.
Available to whom?
Only bona fide research groups will be eligible to access data. Data access requests will be made via an application form detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific eligibility criteria by data custodians. Participants will consent for their anonymised data to be used in this way.
Available for what types of analyses?
Each application will be reviewed based on scientific quality and robustness of the proposed statistical analysis plan. Data request will be appraised by the Principal Investigator and wider Trial Steering Committee on a case-by-case basis with oversight of the Study Statistician.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]) and following approval will be sent via secure file transfer.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16153Study protocol    The Study Protocol will be submitted to a peer rev... [More Details]
16154Statistical analysis plan  [email protected] Access to the Statistical Analyses Plan is subject... [More Details]



Results publications and other study-related documents

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