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Quit by Phone Study: A telephone-based smoking cessation study among low-socioeconomic status smokers in Australia

Tailored Text Messaging versus standard Quitline services for smoking cessation among low-socioeconomic status Australian smokers: a non-inferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000820707
Acronym
QPS
Enrollment
1250
Registered
2022-06-10
Start date
2022-11-04
Completion date
2023-09-15
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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

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.

Sponsors

The University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

There are no exclusion criteria for this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026