Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000325909
Ethics application status
Approved
Date submitted
25/03/2011
Date registered
28/03/2011
Date last updated
28/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive and behavioural support for cigarette smokers trying to quit
Scientific title
The effect on current smokers motivated to quit smoking of cognitive and behavioural cessation support through text messages and education compared to education only on short- and long-term abstinence from cigarette smoking
Secondary ID [1] 259693 0
nil
Universal Trial Number (UTN)
U1111-1119-6393
Trial acronym
COBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 261267 0
Condition category
Condition code
Public Health 259419 259419 0 0
Other public health
Public Health 259432 259432 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomly timed, plus incidental requested text messages, delivered by mobile phone devices; messages contain quit smoking advice and encouragement delivered daily for 1 week pre-quit and 4 weeks post-quit date.
Plus
Participants given a standard paper-based self-help quitting booklet from QUIT Tasmania containing advice and strategies for individuals who want to quit smoking.
Intervention code [1] 264121 0
Treatment: Other
Intervention code [2] 264139 0
Behaviour
Comparator / control treatment
Participants given only the standard paper-based self-help quitting booklet from QUIT Tasmania containing advice and strategies for individuals who want to quit smoking.
Control group
Active

Outcomes
Primary outcome [1] 262227 0
Short term verified abstinence using expired air carbon monoxide (CO) concentration (a biochemical marker of smoking)
Timepoint [1] 262227 0
28 days post quit date
Primary outcome [2] 262228 0
Long term verified abstinence using expired air carbon monoxide (CO) concentration (a biochemical marker of smoking)
Timepoint [2] 262228 0
6 months post quit date
Secondary outcome [1] 273364 0
Ecological Momentary Assessment (EMA) will use hand-held computers running data collection software, programmed specifically for this study. Participants will indicate on the phone each time they smoke a cigarette. The device will log and store the time and date of these events.
Following 4-5 randomly selected cigarette reports per day and 4-5 randomly-selected non-smoking assessments per day, participants will complete an assessment of current mood, withdrawal severity, craving and contextual and situational details. Response data will be stored on the mobile phone device.
Timepoint [1] 273364 0
Daily from one week pre-quit day (Day 0) up to day 28 post-quit date

Eligibility
Key inclusion criteria
Smoking > 10 cigarettes per day for the past 3 years; high motivation to quit smoking; ability to read and write English; willing to consent to and complete research tasks.
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, or have been within the past 3 months; planning to use a smoking cessation pharmacotherapy (bupropion, varenicline, or nicotine replacement therapy) as part of a quit attempt within the next 6 months.

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)
Smokers who are interested in participation will be invited to call a dedicated the study telephone number for more information. During this call, the caller will be screened for eligibility. Eligible callers will then have the study requirements explained to them, and, if they are interested in participating, they will be scheduled for an enrolment session at the study site. During this first study session, interested and eligible individuals will have the study explained to them by a study staff member and, after having an opportunity to ask any questions and to review the study information sheet, they will be asked to provide written informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised centrally using a computer generated permuted-block randomisation strategy.
The computer program used to record participant data will direct research staff to supply a particular hand-held study device after obtaining informed consent and completion of baseline measurements. The study devices will be pre-loaded with either the active or control materials. Similarly training materials will be supplied in a blinded fashion. Allocation concealment will be accomplished using pre-numbered study devices.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2011
Actual
5/05/2011
Date of last participant enrolment
Anticipated
Actual
15/02/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
288
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 3672 0
7000
Recruitment postcode(s) [2] 3673 0
7001
Recruitment postcode(s) [3] 3674 0
7002
Recruitment postcode(s) [4] 3676 0
7004
Recruitment postcode(s) [5] 3677 0
7005
Recruitment postcode(s) [6] 3678 0
7006
Recruitment postcode(s) [7] 3679 0
7007
Recruitment postcode(s) [8] 3680 0
7008
Recruitment postcode(s) [9] 3681 0
7009
Recruitment postcode(s) [10] 3682 0
7010
Recruitment postcode(s) [11] 3683 0
7011
Recruitment postcode(s) [12] 3684 0
7012
Recruitment postcode(s) [13] 3685 0
7015
Recruitment postcode(s) [14] 3686 0
7016
Recruitment postcode(s) [15] 3687 0
7017
Recruitment postcode(s) [16] 3688 0
7018
Recruitment postcode(s) [17] 3689 0
7019
Recruitment postcode(s) [18] 3690 0
7020
Recruitment postcode(s) [19] 3691 0
7021
Recruitment postcode(s) [20] 3692 0
7022
Recruitment postcode(s) [21] 3693 0
7023
Recruitment postcode(s) [22] 3694 0
7024
Recruitment postcode(s) [23] 3695 0
7025
Recruitment postcode(s) [24] 3696 0
7026
Recruitment postcode(s) [25] 3697 0
7027
Recruitment postcode(s) [26] 3698 0
7030
Recruitment postcode(s) [27] 3699 0
7050
Recruitment postcode(s) [28] 3700 0
7051
Recruitment postcode(s) [29] 3701 0
7052
Recruitment postcode(s) [30] 3702 0
7053
Recruitment postcode(s) [31] 3703 0
7054
Recruitment postcode(s) [32] 3704 0
7055
Recruitment postcode(s) [33] 3705 0
7109
Recruitment postcode(s) [34] 3706 0
7112
Recruitment postcode(s) [35] 3707 0
7113
Recruitment postcode(s) [36] 3708 0
7116
Recruitment postcode(s) [37] 3709 0
7117
Recruitment postcode(s) [38] 3710 0
7155
Recruitment postcode(s) [39] 3711 0
7162
Recruitment postcode(s) [40] 3712 0
7163
Recruitment postcode(s) [41] 3713 0
7170
Recruitment postcode(s) [42] 3714 0
7171
Recruitment postcode(s) [43] 3715 0
7172
Recruitment postcode(s) [44] 3716 0
7173
Recruitment postcode(s) [45] 3717 0
7174
Recruitment postcode(s) [46] 3718 0
7175
Recruitment postcode(s) [47] 3719 0
7176
Recruitment postcode(s) [48] 3720 0
7177
Recruitment postcode(s) [49] 3721 0
7178
Recruitment postcode(s) [50] 3722 0
7179
Recruitment postcode(s) [51] 3723 0
7180
Recruitment postcode(s) [52] 3724 0
7182
Recruitment postcode(s) [53] 3725 0
7183
Recruitment postcode(s) [54] 3726 0
7184
Recruitment postcode(s) [55] 3727 0
7185
Recruitment postcode(s) [56] 3728 0
7186
Recruitment postcode(s) [57] 3729 0
7187

Funding & Sponsors
Funding source category [1] 264585 0
Government body
Name [1] 264585 0
National Health & Medical Research Council (NHMRC) Project Grant
Country [1] 264585 0
Australia
Primary sponsor type
Individual
Name
Dr Stuart Ferguson
Address
University of Tasmania
Private Bag 26
Hobart TAS 7001
Country
Australia
Secondary sponsor category [1] 263724 0
Individual
Name [1] 263724 0
Dr Julia Walters
Address [1] 263724 0
Menzies Research Institute Tasmania
Private Bag 23,
Hobart TAS 7000
Country [1] 263724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266723 0
HREC (Tasmania) Network
Ethics committee address [1] 266723 0
Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001
Ethics committee country [1] 266723 0
Australia
Date submitted for ethics approval [1] 266723 0
10/12/2010
Approval date [1] 266723 0
19/12/2010
Ethics approval number [1] 266723 0
H11574

Summary
Brief summary
A controlled clinical trial study design to study the efficacy, for smokers motivated to quit, of a cognitive and behavioural support program using mobile phones in addition to a traditional self-help quitting booklet to test the hypotheses that this intervention will increase short and long term smoking cessation.
Trial website
Trial related presentations / publications
Schuez N, Walters JAE, Frandsen M, et al. Compliance with an EMA Monitoring Protocol and its Relationship with Participant and Smoking Characteristics. Nicotine and Tobacco Research 2013;Sep 19. [Epub ahead of print]

Frandsen M, Walters J, Ferguson SG. Exploring the Viability of Using Online Social Media Advertising as a Recruitment Method for Smoking Cessation Clinical Trials. Nicotine Tob Res 2014;16:247-51.
Public notes

Contacts
Principal investigator
Name 32282 0
Dr Stuart Ferguson
Address 32282 0
University of Tasmania Private Bag 34 UTAS, Hobart, TAS 7001
Country 32282 0
Australia
Phone 32282 0
+61 3 6226 8536
Fax 32282 0
Email 32282 0
Stuart.Ferguson@utas.edu.au
Contact person for public queries
Name 15529 0
Dr Dr Stuart Ferguson
Address 15529 0
University of Tasmania
Private Bag 26
Hobart TAS 7001
Country 15529 0
Australia
Phone 15529 0
+61 3 6226 8536
Fax 15529 0
Email 15529 0
Stuart.Ferguson@utas.edu.au
Contact person for scientific queries
Name 6457 0
Dr Dr Stuart Ferguson
Address 6457 0
University of Tasmania
Private Bag 26
Hobart TAS 7001
Country 6457 0
Australia
Phone 6457 0
+61 3 6226 8536
Fax 6457 0
Email 6457 0
Stuart.Ferguson@utas.edu.au

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
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