Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001333909
Ethics application status
Approved
Date submitted
21/10/2020
Date registered
10/12/2020
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in New South Wales
Scientific title
Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in the New South Wales
Secondary ID [1] 302171 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 318828 0
Cancers 318829 0
Condition category
Condition code
Public Health 316837 316837 0 0
Other public health
Cancer 317718 317718 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the outback quit pack group (n=50) will receive the following:
• An information pack that includes printed practical information about the proper administration of NRT, the NSW QuitKit, an NSW Quitline Brochure and iCanQuit Online Resources Brochure.
• Provision of 12 weeks of NRT – transdermal (e.g. patches) and oromucosal forms (e.g. gum, lozenge) of NRT to be used throughout the intervention period. Participants will initially be mailed an eight-week supply (enough for daily use) of patches and oral forms (gum, lozenge) of NRT. These products include patches (transdermal; 21mg), gum (oromucosal; 4mg) and lozenges (oromucosal 4mg). Participants in the intervention group that specify that they would like a refill for weeks 8-12 will receive a final 4 -week supply of NRT, as per the initial package.
• Proactive referral to NSW Quitline counselling (call-back service – opt out approach). The total number and timing of calls will be tailored to participant need and smoking status, i.e. more frequent calls around relapse crises/quit attempts with an approximate 10 calls over 12 weeks. Counsellors will monitor and encourage correct use of NRT and work with clients to address barriers to its use.

Qualitative sub-study: 25 participants randomised to the Outback Quit Pack group will be selected for the qualitative interview. This interview will be conducted via telephone and the participant will be informed that the interview will be recorded. The majority of the interviews will be with participants who have either not reduced smoking levels or have made only some reduction in cigarettes smoked per day (reduction of >50% at follow-up survey), those who score either within the “normal alcohol consumption range on the baseline AUDIT-C (2 or less) or are identified to be using alcohol at levels that are deemed risky (>3), those participants who are identified as insufficiently active/ sedentary (scoring less than 14 on the Godin’s Leisure Time Activity at baseline) as well as those scoring in the active or moderately active (score=12-23), as well as those participants who are either meeting the nutritional guidelines for fruit and vegetable intake (5 or more serves of vegetables and 2 or more serves of fruit at baseline) as well as those not meeting the guidelines (less than 5 serves of vegetables and less than 2 serves of fruit). Having a mix of those who have engaged with the intervention and those who have not engaged will enable identification of both barriers to engagement and barriers to change for those who do engage. A participant who has engaged in the study will be defined as a participant who has accepted the NSW Quitline referral and the initial NRT and information package (Outback Quit Pack).

Treatment adherence: During the 12-week follow-up survey, questions we will also ask about the specific types of NRT used "In the last 12 weeks, have you used the [patches | gum| lozenges] we sent you to help you quit or cut down smoking?”. Frequency of NRT use will also be assessed by asking participants “How often do you use the [patches | gum |lozenges] we sent you? 1) daily; 2) less than daily; 3) other (please specify)”.
Intervention code [1] 318472 0
Prevention
Intervention code [2] 318473 0
Treatment: Drugs
Intervention code [3] 318474 0
Behaviour
Comparator / control treatment
Participants randomised to the minimal support group (n=50) will receive the following:
• An information sheet designed by the study team will outline available evidence-based smoking cessation supports for quitting smoking, and will be emailed/ sent as a letter to participants randomised to this group.

Participants randomised to this group will be asked about the quit smoking strategies that they utilised over the past 12 weeks and specifically if they have accessed any of the recommenced evidence based smoking cessation supports noted in the letter.
Control group
Active

Outcomes
Primary outcome [1] 324957 0
Feasibility of research procedures which include recruitment and retention rate at 12-weeks post baseline survey, reasons for exclusion or non-consent or withdrawal, recruitment methods (social media verses mail out and compare characteristics).
Timepoint [1] 324957 0
12-week post baseline survey
Secondary outcome [1] 386319 0
Self-reported 30-day point prevalence abstinence
This outcome will be measured by the item "In the last 30 days, have you smoked a cigarette, even a puff?" with response options 1) no, not a puff; 2) 1-5 cigarettes, 3) more than 5 cigarettes.
Timepoint [1] 386319 0
12-week post baseline survey
Secondary outcome [2] 386320 0
Number of cigarettes smoked
Participants will be asked "How many cigarettes do you smoke per day?". A reduction in the number of cigarettes per day, week, or month will be assessed compared to baseline.
Timepoint [2] 386320 0
Baseline and 12-week post baseline survey
Secondary outcome [3] 386324 0
Psychological distress
This will be measured using the 4- item Patient Health Questionnaire (PHQ-4).
Timepoint [3] 386324 0
Baseline and 12-week post baseline survey
Secondary outcome [4] 388058 0
Two-month continuous abstinence.
This will be measured by two composite items. The first is "Have you smoked a cigarette, even a puff, at all since commencing the study? 1) No, not a puff; 2) 1-5 cigarettes; 3) more than 5 cigarettes". The second item is "How long have
A one month grace period will be given the participants.
Timepoint [4] 388058 0
12-week post baseline survey
Secondary outcome [5] 388059 0
Seven day point prevalence abstinence
This will be measured by the item "In the last 7 days, have you smoked a cigarette, even a puff?" with response options 1)yes; 2) no.
Timepoint [5] 388059 0
Three months post baseline survey
Secondary outcome [6] 388060 0
Biochemically verified 30-day point prevalence abstinence.
A validated iCO reading of <6ppm will be considered abstinent. Participants who do not provide a CO reading will be considered smoking. The rationale for the carbon monoxide cut-off is based upon the smoking cessation literature with the general population.
Timepoint [6] 388060 0
Three month post baseline survey
Secondary outcome [7] 388061 0
To assess acceptability and feasibility of Outback Quit Pack Intervention. NRT use will be measured by recording the total number of participants who accept the intervention. During the 12-week follow-up survey, questions we will also ask about the specific types of NRT used "In the last 12 weeks, have you used the [patches | gum| lozenges] we sent you to help you quit or cut down smoking?”. Frequency of NRT use will also be assessed by asking participants “How often do you use the [patches | gum |lozenges] we sent you? 1) daily; 2) less than daily; 3) other (please specify)”. Attitudes about the products are assessed using the following measure “Thinking about your use and experience with the [patches | gum |lozenge] we sent you: 1) were they effective in reducing your cravings; 2) were they easy to use?; 3) Do you consider this product safe to use?; 4) are you concerned about their side effects? On a four point likert scale from very, somewhat, not very, and not at all”. Use of self-help materials will be assessed using the item “In the last 12 weeks, did you use any of the following to help you quit smoking” 1) educational resources –pamphlets, booklets, quitkits with response options yes/no”. For Quitline data the number of calls provided, length of calls, and general topics discussed will be collected by Quitline for all trial participants and will be provided to the study team.
Timepoint [7] 388061 0
Check-ins throughout the study 12-week study period and the 12-week post baseline survey.
Secondary outcome [8] 388062 0
Cravings to smoke
A composite measure will be used that examines frequency of cravings and strength or cravings as recommended in the smoking cessation literature. Frequency of cravings will be measured by asking participants "How often do you get cravings to smoke tobacco?" with response options: a) hourly or more often, b) several times per day, c) at least once a day, d) less than daily, e) never. Strength of cravings will be measured by asking participants "How strong have these urges been?" with response options: a) no urge, b) slight, c) moderate, d) strong, e) very strong, f) extremely strong.
Timepoint [8] 388062 0
Baseline and 12-weeks post baseline survey
Secondary outcome [9] 388063 0
Withdrawal symptoms
Assessment of withdrawal and psychological distress compared to baseline will be conducted using a measure that combines the Patient Health Questionnaire (PHQ-4) and Minnesota Nicotine Withdrawal Scale.
Timepoint [9] 388063 0
Baseline and 12-weeks post baseline survey

Eligibility
Key inclusion criteria
- Current daily tobacco smokers who smoke 10 or more cigarettes per day (a requirement for the use of 21mg nicotine patches)
- Aged 18 years and older
- Current resident of a postcode that meets the ARIA+ Remoteness Area classification scoring of 0.2-2.4 “Inner Regional”, 2.4-5.92 “Outer Regional”, 5.92-10.53 “Remote”, and >10.53 “Very Remote”
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals who have a health condition which contraindicates NRT use without the supervision of a doctor. This includes being pregnant, having a serious heart or circulation problem but not including high blood pressure (as identified during the baseline survey).
- Current resident of a postcode that meets the ARIA+ Remoteness Area classification score of 0-0.2 “Major cities”.

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 research assistant who will determine the eligibility of prospective participants for inclusion in the trial will not be aware of the group allocation of the participant at the point of eligibility screening into the study. Once consent is gained and the baseline survey is completed the research assistant will access the randomisation module on REDCap, at which point both the research assistant and the participant will be made aware of the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be a permutated block of 4 or 6, stratified by rurality (very remote/ remote, outer regional, inner regional) and will be conducted on a 1:1 allocation basis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to present baseline characteristics by group. Descriptive statistics will also be used to present the feasibility study data. The secondary outcome analyses examining the potential effectiveness will involve logistic regressions (associated odds ratio and confidence intervals will be reported) to test if there is a statistically significant difference between groups for the following outcomes: biochemically verified smoking cessation (30 day point prevalence abstinence at 3-months post intervention commencement), seven day point prevalence abstinence, cravings, withdrawal, and number of cigarettes per day.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2021
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
21/05/2021
Actual
Sample size
Target
109
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303920 0
Other Collaborative groups
Name [1] 303920 0
Hunter Cancer Research Alliance
Country [1] 303920 0
Australia
Primary sponsor type
University
Name
The University of Newcaslte
Address
1 University Drive
Callaghan, NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 307434 0
None
Name [1] 307434 0
Address [1] 307434 0
Country [1] 307434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304421 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304421 0
1 University Drive
Callaghan, NSW, 2308
Ethics committee country [1] 304421 0
Australia
Date submitted for ethics approval [1] 304421 0
31/08/2020
Approval date [1] 304421 0
19/11/2020
Ethics approval number [1] 304421 0
H-2020-0313

Summary
Brief summary
The purpose of this study is to determine if the Outback Quit Pack, an information and pharmacological support pack, for those who are trying to quit smoking, is feasible, effective and acceptable to participants.

Who is it for?

You may be eligible for this study if you are an adult residing in rural, regional and remote areas of New South Wales who is trying to quit smoking.

Study details

Participants will be randomly allocated to either:
Arm A: the Outback Quit Pack intervention, and receive nicotine patches, nicotine gum, nicotine lozenge counselling and self-help materials; or,
Arm B: a minimal support group which receives an information sheet about support for quitting smoking.

Participants will complete a survey after the 12-week program to assess their tobacco smoking.

If feasible, the Outback Quit Pack may become a model for cancer risk reduction intervention for other health risk behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96898 0
Dr Eliza Skelton
Address 96898 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96898 0
Australia
Phone 96898 0
+61 240335040
Fax 96898 0
Email 96898 0
[email protected]
Contact person for public queries
Name 96899 0
Dr Eliza Skelton
Address 96899 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96899 0
Australia
Phone 96899 0
+61 240335040
Fax 96899 0
Email 96899 0
[email protected]
Contact person for scientific queries
Name 96900 0
Dr Eliza Skelton
Address 96900 0
Centre for Brain and Mental Health Research
Level 5 McAuley Building, Calvary Mater Hospital
Waratah, NSW, 2298
Country 96900 0
Australia
Phone 96900 0
+61 240335040
Fax 96900 0
Email 96900 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?
All of the data collected in trial after de-identification.
When will data be available (start and end dates)?
Beginning 3-months and ending 5-years after the first manuscript is published.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims in the approved proposal only.
How or where can data be obtained?
Proposals should be directed to Dr Eliza Skelton via email [email protected]
To gain access, requestors will need to sign a data access agreement, this will be provided on receipt of the email.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9809Study protocolIt is the intention of the investigator team to publish a study protocol manuscript. Once published the study protocol citation will be provided in an updated version of this trial registration.   



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4137Plain language summaryNo Please provide a brief summary of the main results... [More Details]
4777Other filesNo Guillaumier. (2022). Outback Quit Pack pilot trial... [More Details]

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