Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000459325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/02/2026
Date registered
Help: Date registered
14/04/2026
Date last updated
Help: Date last updated
22/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
14/04/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
National Which Way? Quit Pack. Mailed smoking and vaping cessation support for Aboriginal and Torres Strait Islander people
Scientific title
Which Way? Quit Pack: Assessing the implementation and impact of a National mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander adolescents and adults
Additional trial identifiers [1] 316548 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records
This national trial was preceded by the ACTRN12623001021662 pilot study.

Health condition
Health condition(s) studied:
Nicotine Dependence 340703 0
Tobacco Smoking 340704 0
Condition category
Condition code
Mental Health 336894 336894 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants who enrol in Which Way? Quit Pack will receive a comprehensive mailed smoking cessation intervention (Quit Pack) delivered to their nominated postal address. The Quit Pack will include: (i) Clothing the Gaps merchandise to celebrate pride in culture, (ii) a written health education story book developed specifically by Which Way? that offers culturally relevant advice and guidance on quitting and Nicotine Replacement Therapy (NRT) use, (iii) an iCOquit® Smokerlyzer, a handheld device that measures carbon monoxide levels in exhaled breath, supporting self-monitoring and motivation for those who indicate using cigarettes at baseline and (iv) a maximum 12-week supply of NRT. NRT will be sent to participants in two separate mail-outs. The first box will be sent at baseline and will contain an 8-week supply of NRT. Six weeks later participants will receive a text-message asking them to confirm if they would like to receive the additional 4week supply of NRT. Upon confirmation, the second box will be sent to participants. Participants can choose from standardised Quit Pack boxes at baseline, including combination NRT options and oral NRT only. If participants choose to receive a follow-up pack, they will be able to select their preferred products (including patches only). Each participant will receive a high dose or low dose pack, determined by their self-reported baseline smoking and vaping behaviours and preferences. Participants will receive a visual study flow to detail the process and relevant timepoints. Participants will also be able to opt in to receive:

- Phone based behavioural counselling with a Tobacco Treatment Specialist. Participants will be able to access phone calls with a Tobacco Treatment specialist. The cessation support team will deliver tailored guidance on behavioural strategies for smoking and/or vaping cessation and NRT use, guided by best-evidence practice and individual participant needs. Behavioural strategies may include, but are not limited to: i) developing personalised cessation plans, including a review of previous quit attempts and barriers; ii) identifying triggers and implementing craving-management strategies (e.g. avoiding cues, using short-acting NRT); iii) strategies to delay the time to first cigarette; iv) education on correct and timely NRT use, particularly during peaking cravings; v) addressing common NRT concerns (e.g. combination therapy, patch site rotation for skin irritation, night time removal if needed). There is no limit to the number of calls a participant can access during the intervention period. Four Aboriginal and Torres Strait Islander team members (women and men) are trained to deliver this support. Online training was delivered by Avondale University over a three day period, and was completed prior to the commencement of the trial.

- Access to an online support and information forum to support quitting. All participants will have access to online information and support to assist their quit attempt. Information content will be hosted on the Which Way website and will include educational content and downloadable resources tailored to support Aboriginal and Torres Strait Islander people in their smoking and vaping cessation journeys that have been co-designed as part of previous trials, and interactive tools to assist with goal setting, tracking progress and staying motivated. Participants will also have access to a secure, password-protected online forum hosted through the existing Which Way? website, and available as a free downloadable mobile app (available for iOS and Android). The forum provides a space for participants to share experiences and quit stories, connect with others in the program. The forum will also be used to share health education content, links, and videos relevant to smoking and vaping cessation. The forum will be managed by the Which Way? team who have received training and education in smoking and vaping cessation and hold or are studying towards tertiary qualifications in social work, medicine and psychology.
Intervention code [1] 333224 0
Lifestyle
Intervention code [2] 333420 0
Treatment: Other
Intervention code [3] 333421 0
Behaviour
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344413 0
Self-reported 7-day point-prevalence smoking abstinence
Timepoint [1] 344413 0
3-, 6- (primary timepoint) and 12-month follow-ups (post enrolment)
Primary outcome [2] 344672 0
Self-reported 7-day point-prevalence vaping abstinence
Timepoint [2] 344672 0
3-, 6- (primary timepoint) and 12-month follow-ups (post enrolment)
Secondary outcome [1] 457876 0
Prolonged smoking abstinence
Timepoint [1] 457876 0
3-, 6- and 12-month follow-ups (post enrolment)
Secondary outcome [2] 457877 0
Smoking quit attempt
Timepoint [2] 457877 0
3-, 6- and 12-month follow-ups (post enrolment)
Secondary outcome [3] 457878 0
Biochemical verification
Timepoint [3] 457878 0
3-, 6- and 12- month follow-ups (post enrolment)
Secondary outcome [4] 457879 0
Reach
Timepoint [4] 457879 0
Baseline
Secondary outcome [5] 457880 0
Study adoption
Timepoint [5] 457880 0
Baseline, 3-, 6- and 12-month follow-ups (post enrolment)
Secondary outcome [6] 457881 0
Intervention adoption
Timepoint [6] 457881 0
3-, 6- and 12-month follow ups (post enrolment)
Secondary outcome [7] 457882 0
Health related quality of life
Timepoint [7] 457882 0
3-, 6- and 12- month follow ups (post enrolment)
Secondary outcome [8] 457883 0
Implementation
Timepoint [8] 457883 0
At end of study
Secondary outcome [9] 457884 0
Smoking maintenance
Timepoint [9] 457884 0
12 month follow up (post enrolment)
Secondary outcome [10] 458793 0
Prolonged vaping abstinence
Timepoint [10] 458793 0
12-month follow-ups (post enrolment)
Secondary outcome [11] 458794 0
Vaping quit attempt
Timepoint [11] 458794 0
12-month follow-ups (post enrolment)
Secondary outcome [12] 458815 0
Vaping maintenance
Timepoint [12] 458815 0
12 month follow up (post enrolment)

Eligibility
Key inclusion criteria
Individuals will be eligible to participate if they self-identify as Aboriginal and/or Torres Strait Islander, consume cigarettes and/or e-cigarettes (vapes) daily, want to quit, and are aged 18 years or older.

Participants who are pregnant at enrolment or become pregnant while in the trial will be recommended to seek advice and support from their General Practitioner (GP) prior to using the optional nicotine replacement therapy (NRT). Consistent with current RACGP guidelines which state that NRT may be recommended for pregnant women who are unable to quit smoking with behavioural support alone, pregnant participants will not be excluded from the study. As oral NRT is the recommended first-line treatment during pregnancy, participants who are pregnant at enrolment will receive a Quit Pack containing oral NRT only. Participants who report low weight (<45kgs) will also only be offered the oral NRT Quit Pack box.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Individuals will be deemed ineligible if they are currently enrolled in any other smoking or vaping cessation program, self-report a previous allergy or hypersensitivity to nicotine or any ingredient in NRT products, or report experiencing any health condition in the six weeks prior to enrolment that are contraindications for NRT use. This includes heart attack, unstable angina, irregular heart rhythm, stroke, mini-stroke, brain aneurysm or vascular malformations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The representativeness of the sample will be assessed by comparing observed proportions to expected proportions based off Australian Bureau of Statistics population data using chi-square goodness of fit tests. The Reach, Effectiveness, Adoption, Implementation, and Maintenance components will be described as counts and percentages with 95% confidence intervals. Associations between participant demographic characteristics and quit rates will also be explored using logistic regression models, adjusting for potentially confounding variables using inverse probability of treatment weighting. Causal Machine Learning models will be used to assess potential heterogeneity in effectiveness of implementation strategies by participant sub-groups. An Intention to Treat (ITT) analysis will be performed for all effectiveness cessation outcomes, where participants with missing smoking or vaping cessation outcomes are imputed as smokers/vapers. Complete case results will also be reported. The proportion of participants with a quit attempt longer than 24 hours will be estimated within the subgroup of participants who have not been continuously abstinent at the 3-, 6- and 12-months follow-ups. Multiple imputation will be used to impute missing outcomes, as well as missing data on confounders.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2026
Actual
29/05/2026
Date of last participant enrolment
Anticipated
31/05/2029
Actual
Date of last data collection
Anticipated
31/05/2030
Actual
Sample size
Target
2000
Accrual to date
810
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321162 0
Government body
Name [1] 321162 0
Department of Health, Disability and Ageing - Medical Research Future Fund (MRFF) Indigenous Health Research Grant
Country [1] 321162 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 323873 0
None
Name [1] 323873 0
Address [1] 323873 0
Country [1] 323873 0
Other collaborator category [1] 283849 0
Charities/Societies/Foundations
Name [1] 283849 0
National Aboriginal Community Controlled Health Organisation
Address [1] 283849 0
Country [1] 283849 0
Australia
Other collaborator category [2] 283850 0
Charities/Societies/Foundations
Name [2] 283850 0
Aboriginal Health & Medical Research Council
Address [2] 283850 0
Country [2] 283850 0
Australia
Other collaborator category [3] 283851 0
Charities/Societies/Foundations
Name [3] 283851 0
Victorian Aboriginal Community Controlled Health Organisation
Address [3] 283851 0
Country [3] 283851 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319695 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 319695 0
Ethics committee country [1] 319695 0
Australia
Date submitted for ethics approval [1] 319695 0
18/09/2025
Approval date [1] 319695 0
08/12/2025
Ethics approval number [1] 319695 0
Ethics committee name [2] 319697 0
Aboriginal Health Research Ethics Committee
Ethics committee address [2] 319697 0
Ethics committee country [2] 319697 0
Australia
Date submitted for ethics approval [2] 319697 0
11/09/2025
Approval date [2] 319697 0
18/11/2025
Ethics approval number [2] 319697 0
Ethics committee name [3] 319698 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [3] 319698 0
Ethics committee country [3] 319698 0
Australia
Date submitted for ethics approval [3] 319698 0
09/09/2025
Approval date [3] 319698 0
13/02/2026
Ethics approval number [3] 319698 0
Ethics committee name [4] 319699 0
VACCHO Human Research Ethics Committee
Ethics committee address [4] 319699 0
Ethics committee country [4] 319699 0
Australia
Date submitted for ethics approval [4] 319699 0
16/10/2025
Approval date [4] 319699 0
19/03/2026
Ethics approval number [4] 319699 0
Ethics committee name [5] 319700 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [5] 319700 0
Ethics committee country [5] 319700 0
Australia
Date submitted for ethics approval [5] 319700 0
31/10/2025
Approval date [5] 319700 0
20/01/2026
Ethics approval number [5] 319700 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 148122 0
Prof Michelle Kennedy
Address 148122 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 148122 0
Australia
Phone 148122 0
+61 2 405 53313
Fax 148122 0
Email 148122 0
[email protected]
Contact person for public queries
Name 148123 0
Michelle Kennedy
Address 148123 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 148123 0
Australia
Phone 148123 0
+61 2 405 53313
Fax 148123 0
Email 148123 0
[email protected]
Contact person for scientific queries
Name 148124 0
Michelle Kennedy
Address 148124 0
IDC Building University of Newcastle, Callaghan, NSW 2308
Country 148124 0
Australia
Phone 148124 0
+61 2 405 53313
Fax 148124 0
Email 148124 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.