Skip to content

Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in New South Wales

Outback Quit Pack: A cancer risk reduction trial for Rural, Regional, and Remote Smokers in the New South Wales

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001333909
Enrollment
109
Registered
2020-12-10
Start date
2021-01-04
Completion date
2021-02-26
Last updated
2021-01-05

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 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.

Interventions

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

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)”.

Sponsors

The University of Newcaslte
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

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”

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”.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026