Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000654752
Ethics application status
Approved
Date submitted
15/03/2022
Date registered
4/05/2022
Date last updated
12/07/2023
Date data sharing statement initially provided
4/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Koori Quit Pack: Mailout smoking cessation support for Aboriginal and Torres Strait Islander people who smoke.
Scientific title
Koori Quit Pack: Feasibility, acceptability, and efficacy of mailout smoking cessation support for Aboriginal and Torres Strait Islander people who smoke
Secondary ID [1] 306419 0
"Nil Known"
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 325530 0
Tobacco Dependence 325588 0
Condition category
Condition code
Mental Health 322933 322933 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the feasibility, and acceptability of Koori Quit Pack, a mailed out smoking cessation package, including optional nicotine replacement therapy (NRT), smoking cessation pamphlets, MyQuitBuddy app, iCanQuit app, Koori Quitline Facebook page, Aboriginal Quitline webpage, and proactive Quitline referral for Aboriginal and Torres Strait Islander people in NSW, ACT and VIC.
Quit Pack: The quit pack will include readily available resources from the Australian Government Department of Health and the Aboriginal Health and Medical Research Council (AH&MRC) such as pamphlets and resources on quitting, info card on MyQuitBuddy App, iCanQuit App, link to Aboriginal Quitline webpage, exercise card or information/motivation, sensory fidgets, shirt or promotional merchandise. As well as health promotion and motivation merchandise.
An offer of nicotine replacement therapy (NRT): Research assistance (RA) will telephone participants prior to commencing the interventions (baseline), at 2-week, 6-week, 10-week and finally at 6-months post-intervention. Each telephone call will last between 20-30 minutes. The RA will check receipt of the mail, provide a brief assessment of smoking behaviours, all participants will be offered the option of support at recruitment, and each follow up time point. Before NRT is provided RA will confirm any possible contraindications with NRT. If participants agree to the offer of NRT they will be asked if they intend to use the NRT in the first week and asked to add postage details for their quit pack. NRT will include 21mg nicotine patches and a number of oral NRT options (lozenge, gum, inhalator) as combination NRT, consistent with the recommended best practice according to the 2019 RACGP smoking cessation guidelines. The RACGP recommends a 10-week course of NRT treatment for effective smoking cessation. We will start with mailing out 2 weeks of NRT supply based on the participants’ preference. At 2 weeks, we will assess adherence, medication preference changes, utilisations and provide a further 4 weeks of NRT supply for two courses (total of 10 weeks).

Behavioural counselling: Participants will be offered a referral to Aboriginal Quitline. The RA will explain that the most effective way to quit smoking is to have something to help with the cravings (the NRT) plus help to manage triggers to smoke (e.g. stress or others smoking around you) like that provided by an Aboriginal Quitline. After describing what Aboriginal Quitline offers, i.e. a dedicated Aboriginal counsellor (profiles available on Aboriginal Quitline webpage https://www.quit.org.au/articles/aboriginal-quitline/), yarning approach, as many or as few calls from Quitline as they would like, help with using the NRT products, the RA will only refer the participant to Aboriginal Quitline if they consent and are interested. One of the benefits of Aboriginal Quitline is that it is able to provide highly flexible and timely support, for example, more frequent calls in the first week immediately following a quit attempt when the risk of smoking relapse, even when using NRT, is highest.
Intervention code [1] 323077 0
Treatment: Other
Intervention code [2] 323078 0
Behaviour
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330699 0
Feasibility

Feasibility will be measured by evaluating rate of adherence to full program, uptake of the resources, use of the offered resources, and adherence of NRT using an audit of study records.
Timepoint [1] 330699 0
2 weeks, 6 weeks (primary endpoint), 10 weeks and 6 months after pack is delivered.
Primary outcome [2] 330700 0
Acceptability

Acceptability will be assessed using self-reported questionnaire. Participants will be asked if they used (yes/no) individual intervention components. If participants report yes use, they will be asked to report usefulness, engagement, and improvement questions which will also include open text fields for qualitative reporting.
Timepoint [2] 330700 0
2 weeks, 6 weeks (primary endpoint), 10 weeks and 6 months after pack is delivered.
Primary outcome [3] 330702 0
Abstinence

Abstinence will be measured using a study specific questionnaire including a self-reported 7-day point prevalence abstinence rates.
Timepoint [3] 330702 0
2 weeks, 6 weeks (primary endpoint), 10 weeks and 6 months after pack is delivered.
Secondary outcome [1] 407242 0
Adherence

Adherence will be measured by participant self-report using study specific questionnaire asking the frequency of use of individual intervention components.
Timepoint [1] 407242 0
2 weeks, 6 weeks and 10 weeks after pack is delivered
Secondary outcome [2] 407245 0
Participant recruitment rate

Assessed by an audit of study database.
Timepoint [2] 407245 0
Baseline, 2 week, 6 week, 10 weeks, 6 months after pack is delivered.
Secondary outcome [3] 407817 0
Participant retention rate

Assessed by the number of participants in each follow up using study database.
Timepoint [3] 407817 0
10 weeks after pack is delivered.

Eligibility
Key inclusion criteria
Participants will be restricted to Aboriginal and Torres Strait Islander people, current smokers, age 16 and above, who live in NSW, ACT or Victoria and smoke daily. Participants will be eligible if they have a plan to quit smoking in the next one month of 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
Completed
Date of first participant enrolment
Anticipated
31/05/2022
Actual
31/05/2022
Date of last participant enrolment
Anticipated
31/05/2023
Actual
7/10/2022
Date of last data collection
Anticipated
30/11/2023
Actual
10/03/2023
Sample size
Target
200
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC

Funding & Sponsors
Funding source category [1] 310769 0
Charities/Societies/Foundations
Name [1] 310769 0
National Heart Foundation Aboriginal and Torres Strait Islander Award
Country [1] 310769 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 312339 0
None
Name [1] 312339 0
Address [1] 312339 0
Country [1] 312339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310345 0
Aboriginal Health & Medical Research Council Ethics Committee of NSW
Ethics committee address [1] 310345 0
Ethics committee country [1] 310345 0
Australia
Date submitted for ethics approval [1] 310345 0
16/11/2021
Approval date [1] 310345 0
18/04/2022
Ethics approval number [1] 310345 0
#1894/21
Ethics committee name [2] 311432 0
University of Newcastle
Ethics committee address [2] 311432 0
Ethics committee country [2] 311432 0
Australia
Date submitted for ethics approval [2] 311432 0
Approval date [2] 311432 0
30/05/2022
Ethics approval number [2] 311432 0
#H-2022-0174

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

Contacts
Principal investigator
Name 117318 0
Dr Michelle Kennedy
Address 117318 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 117318 0
Australia
Phone 117318 0
+61 2 405 53313
Fax 117318 0
Email 117318 0
[email protected]
Contact person for public queries
Name 117319 0
Joley Foster
Address 117319 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 117319 0
Australia
Phone 117319 0
+61 4 675 15850
Fax 117319 0
Email 117319 0
[email protected]
Contact person for scientific queries
Name 117320 0
Michelle Kennedy
Address 117320 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 117320 0
Australia
Phone 117320 0
+61 2 405 53313
Fax 117320 0
Email 117320 0
[email protected]

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.