Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000725864
Ethics application status
Approved
Date submitted
5/07/2012
Date registered
6/07/2012
Date last updated
1/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Financial Intervention for Smoking Cessation Among Low-Income Smokers
Scientific title
A randomised controlled trial examining the effectiveness of a smoking cessation intervention (financial counselling, free Nicotine Replacement Therapy (NRT) and Quitline support) versus free NRT and Quitline support only on reducing smoking in socioeconomically disadvantaged groups
Secondary ID [1] 280781 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
FISCALS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Addiction/Smoking Cessation 286838 0
Condition category
Condition code
Public Health 287151 287151 0 0
Epidemiology
Public Health 287152 287152 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive four telephone-based financial counselling sessions with a qualified financial counsellor who has been trained to be sensitive to smoking cessation issues. Each financial counselling session will be 1 hour in duration and will be conducted on an approximately weekly basis over 4-weeks following baseline. The sessions will focus on three key areas: budgeting, money management and financial goal setting. This will include personalised expense assessments; education on the relationship between financial strain and smoking; advice on bill tracking and how to deal with debts; discussion of financial goals and targeted advice on how to achieve identified goals; and education on frugal living strategies. All intervention participants will also be provided with a personalised budget, including a “if you didn’t smoke” scenario following their initial session, which will be reviewed and discussed at subsequent sessions. In addition, the intervention group will concurently receive the usual gold practice standard intervention including 10-weeks free Nicotine Replacement Therapy (NRT) and call-back support from Quitline commencing following baseline. Participants will nominate their preferred form of NRT, which will be mailed to them by the research team. Dosage will be determined based on the level of nicotine dependence at baseline as measured using the Heaviness of Smoking Index. In addition, participants will receive one on one telephone-based call-back support from Quitline advisors who will provide advice, support and information on smoking cessation. Standard elements of telephone-based cessation counselling include: negotiating a quit date, monitoring and motivating use of NRT, arranging social support and self-reward for abstinence. The number of Quitline counselling sessions each participant engages in and the duration of contact with Quitline will be recorded for each participant.
Intervention code [1] 285208 0
Treatment: Other
Intervention code [2] 285221 0
Lifestyle
Comparator / control treatment
The control group will be given only the usual gold practice standard intervention comprising 10-weeks free Nicotine Replacement Therapy and call-back support from Quitline (as described above).
Control group
Active

Outcomes
Primary outcome [1] 287461 0
Self-reported sustained abstinence from smoking, reported as having quit at each follow-up with no reported smoking at all in the last week. This will be assessed via telephone-based interviews with researchers.
Timepoint [1] 287461 0
2-months post-baseline and 6-months post-quit date
Secondary outcome [1] 298206 0
Change in self-reported financial stress measured using the Index of Financial Stress (Siahpush & Carlin, 2003)
Timepoint [1] 298206 0
Baseline, 2-months post-baseline and 6-months post-quit date
Secondary outcome [2] 298207 0
Change in Quality of Adjusted Life Years (QALYs) as measured by the EQ-5D
Timepoint [2] 298207 0
Baseline, 2-months post-baseline and 6-months post-quit date
Secondary outcome [3] 298229 0
Changes in psychological stress using the Depression Anxiety Stress Scale - 21 (DASS).
Timepoint [3] 298229 0
Baseline, 2-months post-baseline and 6-months post-quit date

Eligibility
Key inclusion criteria
Current daily smokers (at least 10 cigarettes/day); ability to read and understand English; currently in receipt of government benefits; motivated to quit smoking; agree to receive help to quit; willing to make an attempt to quit; willing to consent to and complete research tasks, not currently taking smoking medication (e.g. Champix)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently enrolled in a smoking cessation trial; unable to read/understand English language study materials; no home or mobile telephone; not willing to make an attempt to quit smoking; currently taking smoking medication (e.g. Champix)

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)
Recruitment advertisements will invite smokers who are interested in participation to call a dedicated study phone number for more information. During the initial call, each prospective participant will be screened for eligibility. Eligible participants will then be provided with information about the project over the telephone and will be asked if they are interested in participating. If so, all eligible and willing participants will be asked to provide informed verbal consent to participate. Those consenting to participate will be asked to provide their current contact details to make an appointment for the research team to call them approximately one week later for their first interview. All participants will be randomised at their first interview, one week following recruitment. Allocation concealment will be achieved via central computer-based randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated block randomisation strategy will be employed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
8/04/2013
Date of last participant enrolment
Anticipated
19/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1046
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285567 0
Government body
Name [1] 285567 0
National Health and Medical Research Council
Country [1] 285567 0
Australia
Primary sponsor type
Individual
Name
Professor Richard Mattick
Address
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 284404 0
None
Name [1] 284404 0
Address [1] 284404 0
Country [1] 284404 0
Other collaborator category [1] 276904 0
Individual
Name [1] 276904 0
Dr Kristy Martire
Address [1] 276904 0
School of Psychology
University of New South Wales
Sydney, NSW 2052
Country [1] 276904 0
Australia
Other collaborator category [2] 276905 0
Individual
Name [2] 276905 0
Dr Billie Bonevski
Address [2] 276905 0
School of Medicine and Public Health
University of Newcastle
Callaghan, NSW 2308
Country [2] 276905 0
Australia
Other collaborator category [3] 276906 0
Individual
Name [3] 276906 0
Professor Ron Borland
Address [3] 276906 0
Cancer Council Victoria
1 Rathdowne St
Carlton Vic 3053
Country [3] 276906 0
Australia
Other collaborator category [4] 276907 0
Individual
Name [4] 276907 0
Professor Christopher Doran
Address [4] 276907 0
School of Medicine and Public Health
University of Newcastle
Callaghan, NSW 2308
Country [4] 276907 0
Australia
Other collaborator category [5] 276908 0
Individual
Name [5] 276908 0
Professor Wayne Hall
Address [5] 276908 0
University of Queensland Centre for Clinical Research
University of Queensland
Herston, QLD, 4029
Country [5] 276908 0
Australia
Other collaborator category [6] 276909 0
Individual
Name [6] 276909 0
Professor Michael Farrell
Address [6] 276909 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country [6] 276909 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287585 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 287585 0
Ethics committee country [1] 287585 0
Australia
Date submitted for ethics approval [1] 287585 0
05/06/2012
Approval date [1] 287585 0
12/07/2012
Ethics approval number [1] 287585 0
HC12318

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34395 0
Prof Richard Mattick
Address 34395 0
National Drug and Alcohol Research Centre University of New South Wales Sydney, NSW 2052
Country 34395 0
Australia
Phone 34395 0
+61 (02) 9385 0333
Fax 34395 0
Email 34395 0
[email protected]
Contact person for public queries
Name 17642 0
Ryan Courtney
Address 17642 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country 17642 0
Australia
Phone 17642 0
+61 (02) 8936 1004
Fax 17642 0
Email 17642 0
[email protected]
Contact person for scientific queries
Name 8570 0
Professor Richard Mattick
Address 8570 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country 8570 0
Australia
Phone 8570 0
+61 (02) 9385 0333
Fax 8570 0
Email 8570 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseSmoking and finances: Baseline characteristics of low income daily smokers in the FISCALS cohort.2017https://dx.doi.org/10.1186/s12939-017-0643-6
EmbaseFactors associated with Quitline and pharmacotherapy utilisation among low-socioeconomic status smokers.2019https://dx.doi.org/10.1016/j.addbeh.2018.09.029
N.B. These documents automatically identified may not have been verified by the study sponsor.