Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000840684
Ethics application status
Approved
Date submitted
10/07/2023
Date registered
4/08/2023
Date last updated
25/06/2024
Date data sharing statement initially provided
4/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A group-based smoking cessation program for Aboriginal and Torres Strait Islander women
Scientific title
Feasibility and acceptability of a culturally responsive group-based smoking cessation program for Aboriginal and Torres Strait Islander women
Secondary ID [1] 309846 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 330284 0
Tobacco Dependence 330700 0
Condition category
Condition code
Mental Health 327147 327147 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test the feasibility, and acceptability of a Group-based smoking cessation. The group-based program will be provided over six sessions. The first three sessions will focus on the harm of smoking, mechanisms of addiction, and benefits of smoking cessation. Participants will have the option of choosing either an online or a face-to-face group-based intervention provided at participating Aboriginal Community Controlled Health Organisations (Waminda Aboriginal Health Service and Birra Li Aboriginal Health Service).
Program staff
A group smoking cessation facilitation manual and resources have been co-developed with Aboriginal Health Workers and practitioners (AHW/P) and two partnering Aboriginal maternal health services. All relevant AHW/Ps and maternal health staff will be trained in both the National Aboriginal Community Controlled Health Organisation (NACCHO) accredited smoking cessation training and a further 3 hours of training according to the group smoking cessation manual and resources by a tobacco treatment specialist, Worimi woman Joley Foster prior to group facilitation. This will involve counselling protocol, quality control procedures, NRT adverse events, and role playing of project procedures. The counsellors will meet as required, with direct contact with the tobacco treatment specialist for any additional supports required, and fortnightly throughout the project for quality control, supervision, and case review. The tobacco treatment specialist will note any issues with project implementation, additional supports or resources needed for project implementation to assist in the feasibility data collection.
Number of groups: 10-20 participants will be included in each group session (with 1 facilitator per group) with the total number of groups to be determined based on the total number of recruited participants, as well as individual community needs and capacity.
Duration of Intervention: To effectively meet the needs of participants and the participating Aboriginal Community Controlled Health Organisations, the intervention will be able to be delivered flexibly. Services will have the option of delivering six 60-90 minute sessions either weekly or fortnightly, or a compressed intervention delivered as a one day program. The one-day program retains all program activities and behavioural change techniques, but is structured to enable delivery of content in a concentrated manner.
The sessions will run as follow.
Session 1: Smoking harms and the benefits of quitting
• Understand the potential health risks associated with smoking.
• Understand the multitude of health benefits that can be gained by quitting smoking.
• Discuss practical approaches to minimise exposure to passive smoke.
Session 2: Reasons for smoking & challenges
• Reflect on personal motivations and reasons for quitting smoking, exploring the potential benefits and positive changes that can be experienced.
• Reflect and understand motivations behind smoking, which may include social influences, stress relief, habit formation, peer pressure, or psychological factors.
• Understand the difficulties and obstacles often encountered when attempting to quit smoking.
Session 3: Nicotine dependence, smoking cessation supports & starting the quitting process
• Understand how nicotine affects the brain and creates a physiological and psychological dependency.
• Understand how NRT and other cessation supports in the journey of quitting smoking.
• Understand strategies for effectively addressing the challenges that may have arisen during previous attempts to quit smoking.
• Initiate the process of creating a comprehensive quit plan to enhance successfully quitting.
• Combination NRT will be offered based on preference and participants will be instructed to start using the NRT on their quit day.
Session 4: Behaviour Change Techniques & quit plan
• Discuss replacement behaviours for managing smoking urges and cultivating new habits.
• Discuss relapse prevention including strategies and techniques to anticipate, manage, and ultimately avoid returning to smoking after quitting.
• Finalize the quit plan and share with the group.
Session 5: Successes, barriers, and positive self-building
• Learning about motivation, building habits and self-rewards.
• Participants will share stages to talk about change after quitting.
• Discuss and explore strategies for social support to stay smoke-free.
Session 6: Graduation
• Empower participants.
• Discuss future plans beyond the six weeks.
• Reinforcing learning so far.
Intervention code [1] 326281 0
Treatment: Other
Intervention code [2] 326282 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335017 0
Feasibility

The feasibility of the intervention will be assessed by employing a composite outcome approach. This will involve conducting a survey and reviewing study records to evaluate various factors, including the recruitment rate, attendance to sessions, retention rate, and uptake of resources.
Timepoint [1] 335017 0
Baseline, 3 weeks and 6 weeks post-commencement of the group sessions (primary endpoint)
Primary outcome [2] 335018 0
Acceptability

Acceptability will be assessed using a self-reported questionnaire and interview. Participants will be asked if they find the group sessions useful. Participants and intervention providers will be asked to report usefulness, engagement, and areas of improvement. This will be combined to create a composite primary outcome.
Timepoint [2] 335018 0
Baseline, 3 weeks and 6 weeks post-commencement of the group sessions (primary endpoint)
Secondary outcome [1] 422719 0
Quit attempt

Participants will be asked if they had made a quit attempt at each follow-up time point.
Timepoint [1] 422719 0
Baseline, 3 weeks and 6 weeks post-commencement of the group sessions
Secondary outcome [2] 422720 0
Abstinence

Abstinence will be measured using a study-specific questionnaire including self-reported continuous and 7-day point prevalence abstinence rates.
Timepoint [2] 422720 0
Baseline, 3 weeks and 6 weeks post-commencement of the group sessions
Secondary outcome [3] 424320 0
Barriers and facilitators (Primary outcome)

To gain insights into the barriers and facilitators associated with the intervention, semi-structured interviews will be conducted with both participants and intervention providers. The barriers and facilitators identified through semi-structured interviews with participants and intervention providers will be combined to create a composite primary outcome.
Timepoint [3] 424320 0
6 weeks post-commencement of the group sessions

Eligibility
Key inclusion criteria
Participants will be restricted to Aboriginal and Torres Strait Islander women of reproductive age (16–49 years), residents of New South Wales, currently smoke 1 or more cigarettes per day, and are able to attend group-sessions.
Minimum age
16 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Aboriginal people,
Non-smokers,
Males.
Age less than 16 and above 49 years old,
Aboriginal and Torres Strait Islander people who live outside of NSW,
Participants who are currently part of other smoking cessation trials.

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
In accordance with the Consolidated Standards of Reporting Trials statement guideline for feasibility and pilot studies, a descriptive summary of the baseline characteristics of participants and follow-up measures will be conducted and reported. Data will be approached in a complete case analysis and in an intention-to-treat base by considering all individuals lost to follow-up still smoke.
Data obtained from interviews with audio-recordings will be transcribed and imported into NVivo 12 and will be double coded and analysed using thematic analysis following the method described in Braun and Clarke.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/05/2024
Actual
29/05/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
11/10/2024
Actual
Sample size
Target
100
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314033 0
Charities/Societies/Foundations
Name [1] 314033 0
National Heart Foundation Aboriginal and Torres Strait Islander Award
Country [1] 314033 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Dr, Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 315923 0
None
Name [1] 315923 0
Address [1] 315923 0
Country [1] 315923 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313167 0
Aboriginal Health & Medical Research Council Ethics Committee of NSW
Ethics committee address [1] 313167 0
35 Harvey Street
Little Bay NSW 2036
Ethics committee country [1] 313167 0
Australia
Date submitted for ethics approval [1] 313167 0
08/08/2023
Approval date [1] 313167 0
30/10/2023
Ethics approval number [1] 313167 0
2170/23
Ethics committee name [2] 315583 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 315583 0
http://www.newcastle.edu.au/research/research-services/human-ethics/
Ethics committee country [2] 315583 0
Australia
Date submitted for ethics approval [2] 315583 0
Approval date [2] 315583 0
27/11/2023
Ethics approval number [2] 315583 0
H-2023-0432
Ethics committee name [3] 315584 0
Hunter New England Human Research Ethics Committee
Ethics committee address [3] 315584 0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Ethics committee country [3] 315584 0
Australia
Date submitted for ethics approval [3] 315584 0
21/09/2023
Approval date [3] 315584 0
22/09/2023
Ethics approval number [3] 315584 0
2023-ETH01745

Summary
Brief summary
Smoking imposes a wide range of impacts on women of reproductive age, beginning with its effect on fertility and extending throughout pregnancy and beyond. A comprehensive, and culturally appropriate smoking cessation interventions are needed to achieve a healthy generation. 44% of Aboriginal women continue to smoke during the first 20 weeks of pregnancy. Only one in ten Aboriginal women who smoke manage to quit successfully during pregnancy. This statistic is largely attributed to the lack of culturally relevant support, leaving many Aboriginal women longing for assistance to overcome the health risk posed to their babies and their own well-being.
Over the past 4 years the Which Way? project has worked in partnership with Aboriginal and Torres Strait Islander women and communities to develop an Indigenous-led evidence base for smoking cessation care. Our goal is to provide Aboriginal and Torres Strait Islander women access to high quality, evidence based and meaningful smoking cessation care to empower smoke-free generations. This program has been built based on requests from Aboriginal and Torres Strait Islander women for group-based supports. This program was developed using a co-designed approach in partnership with Birra-Li Aboriginal Maternal Infant Health Service and Waminda South Coast Women’s Health and Welfare Aboriginal Corporation and the University of Newcastle. This program has been designed to provide communities with key information, resources, and strategies to support their smoking cessation journey in a group-based setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127226 0
A/Prof Michelle Kennedy
Address 127226 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127226 0
Australia
Phone 127226 0
+61 2 405 53313
Fax 127226 0
Email 127226 0
michelle.kennedy11@newcastle.edu.au
Contact person for public queries
Name 127227 0
Ms Joley Foster
Address 127227 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127227 0
Australia
Phone 127227 0
+61 4 675 15850
Fax 127227 0
Email 127227 0
joley.foster@newcastle.edu.au
Contact person for scientific queries
Name 127228 0
A/Prof Michelle Kennedy
Address 127228 0
University of Newcastle | University Drive | VA Building | CALLAGHAN, NSW, 2308, Australia
Country 127228 0
Australia
Phone 127228 0
+61 2 405 53313
Fax 127228 0
Email 127228 0
michelle.kennedy11@newcastle.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.