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Trial registered on ANZCTR


Registration number
ACTRN12623001021662
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
20/09/2023
Date last updated
14/10/2024
Date data sharing statement initially provided
20/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Which Way? Quit Pack- Mailout smoking cessation support for Aboriginal and Torres Strait Islander people who smoke
Scientific title
Which Way? Quit Pack- Evaluating the effect of Mailout smoking cessation support on the rate of smoking cessation for Aboriginal and Torres Strait Islander people who smoke
Secondary ID [1] 310083 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is built up on a pilot study conducted to evaluate the feasibility and acceptability of mailout smoking cessation intervention among Aboriginal and Torres Strait Islander People who smoke, with registration number ACTRN12622000654752.

Health condition
Health condition(s) or problem(s) studied:
Smoking 330634 0
Tobacco Dependence 330635 0
Condition category
Condition code
Mental Health 327461 327461 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention. The intervention will be 3 months in duration and includes three components:
(1) Provision of a Quit Pack: participants will be mailed a Quit Pack. The Quit Pack includes readily available universal quitting resources from sources such as Quit Victoria. The Quit Pack includes pamphlets and resources on quitting, an information card on existing government-provided support options (e.g., MyQuitBuddy App, iCanQuit App, link to Aboriginal Quitline webpage), as well as health promotion and Aboriginal merchandise (e.g., a hat, socks or beanie from Clothing the Gaps, a Victorian Aboriginal led and controlled, and majority Aboriginal owned, social enterprise). Participants will be asked whether they have received the posted package and adherence to the resources will be evaluated at each follow-up.
(2) Multiple offers of Nicotine Replacement Therapy (NRT): participants will be offered a 12-week course of combination NRT consistent with RACGP recommendations at baseline during the initial phone call post enrolment. Intervention check-ins will take place at 2, 6, and 10 weeks for all participants to allow for re-assessment of required strength and preferences regarding formulations of NRT. Available NRT will include 21mg nicotine patches and faster-acting oral NRT formulations (lozenge, gum, inhalator) as combination NRT, consistent with RACGP smoking cessation guidelines. Participants who want to use NRT will have it mailed to their homes after each check-in time point.
(3) Multiple offers of behavioural counseling. A Research Assistant will explain that the most effective way to quit smoking is to combine a combination of NRT with support to manage cravings and triggers to smoke, which is provided by Aboriginal Quitline. All participants will be offered a call from Aboriginal Quitline (proactive referral) at each follow-up contact starting from the initial phone call post enrolment and Quitline will call those who consent. Quitline will encourage and monitor the use of supplied NRT, explore any barriers to use, and will check for correct techniques to help maximise the effectiveness of the supplied products. Quitline will also provide written and other resources as required and can link participants up with local support groups if requested.
Intervention code [1] 326483 0
Treatment: Other
Intervention code [2] 326484 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335322 0
Smoking cessation

This will be measured by self-reported 7-day point-prevalence abstinence at 6 months follow-up. Participants will be asked whether they have smoked, even a puff, in the last 7 days at each follow-up time point in line with recommendations from the Society for Research in Nicotine and Tobacco.
Timepoint [1] 335322 0
6 months post-enrollment (refers to data collection at 6 months for each participant from their enrollment date)
Primary outcome [2] 335323 0
Smoking cessation

This will be measured by self-reported 7-day point-prevalence abstinence at 3 months follow-up. Participants will be asked whether they have smoked, even a puff, in the last 7 days at each follow-up time point in line with recommendations from the Society for Research in Nicotine and Tobacco.
Timepoint [2] 335323 0
3 months post-enrollment (refers to data collection at 3 months for each participant from their enrollment date)
Secondary outcome [1] 423946 0
Participant recruitment

The number of self-referrals from advertisements and the number of self-referring individuals who meet eligibility criteria will be recorded by the Research Assistant to give an indication of intervention reach.
Timepoint [1] 423946 0
Baseline (refers to the initial data collection point for each participant upon their enrollment into the study)
Secondary outcome [2] 423947 0
Participant uptake and adherence to intervention components

Uptake of each of the offered smoking cessation support strategies included in the Quit Pack and adherence to combined NRT will be recorded at each follow-up time point. Apps: Participants will be asked at each follow-up point if they accessed the MyQuitBuddy or the iCanQuit Apps and for those that accessed, the frequency and duration of use will be recorded. Quitline: The Research Assistant will keep records of participant acceptance of Quitline referrals at baseline for all participants. NRT: The Research Assistant will keep records of participant acceptance of cNRT. At each follow-up, participants will be asked to self-report their use of mailed NRT. Uptake and adherence will be measured as a composite secondary outcome.
Timepoint [2] 423947 0
Baseline, 3 months, and 6 months follow-up post-enrollment.

Baseline: refers to the initial data collection point for each participant upon their enrollment into the study.
3 months: refers to data collection at 3 months for each participant from their enrollment date.
6 months: refers to data collection at 6 months for each participant from their enrollment date.
Secondary outcome [3] 423948 0
Quit attempt

Participants will be asked to self-report their number of quit attempts lasting >24 hours in the preceding period at each follow-up time point.
Timepoint [3] 423948 0
3 months, and 6 months follow-up post-enrollment.

3 months: refers to data collection at 3 months for each participant from their enrollment date.
6 months: refers to data collection at 6 months for each participant from their enrollment date.
Secondary outcome [4] 423949 0
Continuous abstinence

Continuous abstinence will be measured by self-reported abstinence. Participants will be asked whether they have smoked since their last follow-up.
Timepoint [4] 423949 0
3 months, and 6 months follow-up post-enrollment.

3 months: refers to data collection at 3 months for each participant from their enrollment date.
6 months: refers to data collection at 6 months for each participant from their enrollment date.
Secondary outcome [5] 423952 0
Participant perceptions of intervention acceptability, and barriers and enablers to intervention use

Acceptability of the Quit Pack will be determined through the inclusion of questions exploring engagement and usefulness of intervention components in each follow-up survey and through yarning interviews at 3- and 6- months follow-up.
Timepoint [5] 423952 0
3 months, and 6 months follow-up post-enrollment.

3 months: refers to data collection at 3 months for each participant from their enrollment date.
6 months: refers to data collection at 6 months for each participant from their enrollment date.
Secondary outcome [6] 424340 0
Participant retention rate

The number of participants who completed the follow-up surveys will be recorded by the Research Assistant to give an indication of intervention reach.
Timepoint [6] 424340 0
3 months, and 6 months follow-up post-enrollment.

3 months: refers to data collection at 3 months for each participant from their enrollment date.
6 months: refers to data collection at 6 months for each participant from their enrollment date.

Eligibility
Key inclusion criteria
To be eligible to participate, individuals will need to self-identify as an Aboriginal or Torres Strait Islander current daily smoker aged 16 years and above, who resides in a participating state or territory (NSW, Victoria, and the ACT), and plans to quit smoking in the 30 days following enrolment to the program.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Aboriginal people,
Non-smokers,
Age less than 16 years old,
Aboriginal and Torres Strait Islander people who live outside of NSW, ACT or Victoria

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
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/10/2023
Actual
2/10/2023
Date of last participant enrolment
Anticipated
10/10/2024
Actual
9/08/2024
Date of last data collection
Anticipated
5/02/2025
Actual
Sample size
Target
500
Accrual to date
Final
747
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC

Funding & Sponsors
Funding source category [1] 314248 0
Government body
Name [1] 314248 0
Australian Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 314248 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 316180 0
None
Name [1] 316180 0
Address [1] 316180 0
Country [1] 316180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313365 0
Aboriginal Health & Medical Research Council Ethics Committee of NSW
Ethics committee address [1] 313365 0
Ethics committee country [1] 313365 0
Australia
Date submitted for ethics approval [1] 313365 0
10/08/2023
Approval date [1] 313365 0
18/04/2022
Ethics approval number [1] 313365 0
1894/21

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

Contacts
Principal investigator
Name 127898 0
A/Prof Michelle Kennedy
Address 127898 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127898 0
Australia
Phone 127898 0
+61 2 405 53313
Fax 127898 0
Email 127898 0
michelle.kennedy11@newcastle.edu.au
Contact person for public queries
Name 127899 0
Joley Foster
Address 127899 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127899 0
Australia
Phone 127899 0
+61 4 675 15850
Fax 127899 0
Email 127899 0
joley.foster@newcastle.edu.au
Contact person for scientific queries
Name 127900 0
Michelle Kennedy
Address 127900 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127900 0
Australia
Phone 127900 0
+61 2 405 53313
Fax 127900 0
Email 127900 0
michelle.kennedy11@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.