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
The University of Newcaslte
109 participants
Jan 4, 2021
Interventional
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- 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”.
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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 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)”.
Locations(1)
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ACTRN12620001333909