Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000506594
Ethics application status
Approved
Date submitted
5/04/2024
Date registered
24/04/2024
Date last updated
24/04/2024
Date data sharing statement initially provided
24/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding Role of Nicotine Vaping Products in Smoking Cessation: A Qualitative Study
Scientific title
Understanding experiences of smokers and ex-smokers use of nicotine vaping products (NVPs) for smoking cessation.
Secondary ID [1] 311634 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Sub-study of ACTRN12621000076875 and ACTRN12622001147774

Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking 333075 0
Condition category
Condition code
Public Health 329764 329764 0 0
Health service research
Mental Health 329825 329825 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this qualitative research is to gain insights into people’s experiences using nicotine vaping products (NVPs) for smoking cessation, and insights into subsequent cessation of NVP use. These insights will be used to further understand the cessation trajectory of smokers who use NVPs as a quitting aid, and to help guide the development of a text message intervention aimed at increasing smoking cessation among those using NVPs, and to assist with switching away from continued NVP use once smoking cessation has been achieved. There is currently a lack of research in this specific area
of smoking cessation, and this study aims to enrich knowledge in this area.

UNSW, NDARC’s Tobacco Research Group (TRG) have successfully built and implemented a tailored text message program for smoking cessation (HC210410). The text message program uses messaging based on a behavioural change model, and some messages are tailored to individual smokers’ quitting goals. The program uses pre-written messages, a virtual “Quit Buddy” called Lou and contains links to other resources.
Additionally, there is an interactive option for people who want additional text-message support. This research aims to build upon this existing text message program to specifically target support for smokers using NVPs to quit smoking, and also assist former smokers with continued vape use to switch to a smoke-free and vape-free status.

Participants from a previous quit smoking clinical trial who have experience using NVPs for smoking cessation and have reached different points in their quit journey will be asked to participate in this qualitative project. The study will use in-depth interviews, approximately one hour in duration, to explore the barriers and facilitators of quitting smoking using NVPs and gain insight into how ex-smokers switch away from NVP use. These insights will be further explored and built upon in focus group sessions (approximately 90 minutes in duration), which will allow participants to share their ideas for a text message program that helps smokers quit both tobacco smoking and vaping.
This can include changes to the existing types of messages, message style, how specific or tailored they are and other features.
Intervention code [1] 328094 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337544 0
Understanding smokers' and ex-smokers' experiences of using nicotine vaping products (NVPs) for smoking cessation
Timepoint [1] 337544 0
At one-off in-depth interviews approximately 1 week after enrollment
Primary outcome [2] 337545 0
Gaining smokers' and ex-smokers' feedback on a text message intervention for smoking cessation among those using NVPs; and abstinence of NVP use after using them to quit smoking cigarettes (i.e., dual quitting).
Timepoint [2] 337545 0
At focus group sessions held 2-4 weeks after in-depth interviews have been conducted.
Secondary outcome [1] 432536 0
Gaining insights into participant experiences during tobacco smoking quit attempt with the use of an NVP.
Timepoint [1] 432536 0
At focus group sessions held 2-4 weeks after in-depth interviews have been conducted.
Secondary outcome [2] 433154 0
Gaining insights into "dual switching" (ie quitting use of tobacco and NVPs), whereby a participant quits both tobacco use and NVP use.
Timepoint [2] 433154 0
At one-off in-depth interviews approximately 1 week after enrollment, and at focus group sessions held 2-4 weeks after in-depth interviews have been conducted.

Eligibility
Key inclusion criteria
Participants from a previous smoking cessation clinical trial (UNSW HREC HC191025/ACTRN12617001324303) who were allocated to the NVP group, and reported use of their allocated study product, will be invited to take part in this research project. Participants must have also consented to being contacted about future studies and re-use of previous trial data.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Qualitative data from both in-depth interviews and NGT groups will be transcribed and analysed in accordance with Neale's model of Iterative Categorization (IC). IC sets out clear, standardised and pre-defined stages for organising qualitative data. Codes will be generated inductively. Once codes have been identified, they will be grouped into overarching themes and subthemes for later thematic analyses and interpretation.
NGT focus group data will be analyzed through steps. Data from the focus groups will firstly be transcribed and responses from participants will be identified and categorized based on the questions asked. The compiled list of ranked responses from the group will be collated and both a frequency and content analysis will be performed afterwards. A frequency analysis will be used to quantify the number of times a type of response was given, and a content analysis will be used to identify and group together emergent themes. Further reflexive analysis will be used to interpret participant responses.
Formatted scripts will be imported in NVivo. Thematic maps will be generated to help understand relationships in themes and developed using the scissor-and-sort technique. Reflexive analysis will occur after these steps have been performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315957 0
Charities/Societies/Foundations
Name [1] 315957 0
National Heart Foundation of Australia/Future Leader Fellowships (ID105983)
Country [1] 315957 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney
Address
Country
Australia
Secondary sponsor category [1] 318098 0
None
Name [1] 318098 0
Address [1] 318098 0
Country [1] 318098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314784 0
UNSW HREA Panel G: Health, Medical, Community and Social
Ethics committee address [1] 314784 0
humanethics@unsw.edu.au
Ethics committee country [1] 314784 0
Australia
Date submitted for ethics approval [1] 314784 0
26/02/2024
Approval date [1] 314784 0
18/04/2024
Ethics approval number [1] 314784 0
iRECS5873

Summary
Brief summary
Participants from a previous quit smoking clinical trial who have experience using NVPs for smoking cessation and have reached different points in their quit journey will be asked to participate in this qualitative project. The study will use in-depth interviews to explore the barriers and facilitators of quitting smoking using NVPs and gain insight into how ex-smokers switch away from NVP use. These insights will be further explored and built upon in focus group sessions, which will allow participants to share their ideas for a text message program that helps smokers quit both tobacco smoking and vaping. This can include changes to the existing types of messages, message style, how specific or tailored they are and other features.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132718 0
A/Prof Ryan Courtney
Address 132718 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052
Country 132718 0
Australia
Phone 132718 0
+61 2 9065 7655
Fax 132718 0
Email 132718 0
r.courtney@unsw.edu.au
Contact person for public queries
Name 132719 0
A/Prof Ryan Courtney
Address 132719 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052
Country 132719 0
Australia
Phone 132719 0
+61 2 9065 7655
Fax 132719 0
Email 132719 0
r.courtney@unsw.edu.au
Contact person for scientific queries
Name 132720 0
A/Prof Ryan Courtney
Address 132720 0
National Drug and Alcohol Research Centre The University of New South Wales Sydney NSW 2052
Country 132720 0
Australia
Phone 132720 0
+61 2 9065 7655
Fax 132720 0
Email 132720 0
r.courtney@unsw.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.