Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000613808
Ethics application status
Approved
Date submitted
30/05/2012
Date registered
8/06/2012
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Planning, timing and quit success: A randomised controlled trial.
Scientific title
In smokers using a web-based intervention to quit, does a recommendation to implement the quit attempt immediately and/or adherence to a structured planning protocol increase the likelihood of achieving 6-month sustained abstinence?
Secondary ID [1] 280567 0
Nil
Universal Trial Number (UTN)
U1111-1131-2505
Trial acronym
QIPT (Quitting Immediately and/or Planning Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use, addiction and abstention 286571 0
Condition category
Condition code
Public Health 286845 286845 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a 2x2 crossover trial, with participants allocated to intervention or control on both of the following arms:

Arm 1: Immediate implementation: In this arm smokers will be encouraged (recommended) to quit immediately, or as soon as practically possible (e.g., if they need to obtain medication or use it for a period before actually quitting). Those who have already decided to quit will be encouraged to implement their decision immediately. Others will be encouraged to take the next step toward quitting as soon as possible (this may involve getting medication), and implement the quit attempt immediately they have done so. These recommendations will take place via questions in the automated QuitCoach assessment, each time the participant completes the assesment. The control aspect of this is to quit in their own time, without any systematic encouragement to bring it forward.

Arm 2: Structured Planning intervention: The structured planning augmentation of the QuitCoach will consist of highly prescriptive instructions for planning a quit attempt. Key aspects of the structured planning intervention are informed by the theory of implementation intentions. It will be delivered via modifications and additions to the basic QuitCoach tailored advice, and through a section of the QuitCoach website containing a set of tools to facilitate implementation. The control condition will receive the basic QuitCoach.

Participants can be randomised to either: No immediate implementation nor structured planning; no immediate implementation but receiving structured planning; receiving recommendation to quit immediately but no structured planning; or receiving both interventions.

Regardless of to which of the four possible study arms the participant has been randomised, frequency of use of the QuitCoach is at the discretion of the participant. Thus, there is no set endpoint for delivery of the intervention. All participants will be reminded to return via emails sent periodically over several weeks and scheduled according to their readiness to quit, but we anticipate that most will complete the assessment only once (when they join the study). It is possible that those allocated to receive the structured planning intervention will return more frequently, as for this group the QuitCoach will include a greater selection of tools potentially motivating return.
Intervention code [1] 284953 0
Behaviour
Intervention code [2] 284999 0
Lifestyle
Comparator / control treatment
Active control – standard treatment (public version of QuitCoach program and associated resources)
Control group
Active

Outcomes
Primary outcome [1] 287199 0
Sustained abstinence, reported having quit for 6 months and no reported smoking at all in last week. Assessed via a web-based questionnaire following an emailed invitation to complete; failures to respond will be phoned to complete the assessment.
Timepoint [1] 287199 0
TP: 6 months after quit date
Secondary outcome [1] 297611 0
Making a quit attempt. Assessed via a web-based questionnaire following an emailed invitation to complete; failures to respond will be phoned to complete the assessment.
Timepoint [1] 297611 0
The initial (2-week) follow-up
Secondary outcome [2] 297612 0
Point prevalence (7 days) quit. Assessed via a web-based questionnaire following an emailed invitation to complete; failures to respond will be phoned to complete the assessment.
Timepoint [2] 297612 0
The initial (2-week) follow-up, and at 6 months follow-up

Eligibility
Key inclusion criteria
Smokers who want to quit, who are using the QuitCoach, and at recruitment have not committed to a quit attempt in the next day (Rapid Implementation arm) or had quit for up to 4 days (Structured Planning arm)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-smokers, ex-smokers, people not ready to quit (defined as reporting not planning to make a quit attempt in the next month), or quit for more than 4 days, and those reporting a mental health condition for which they are taking medication.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be recruited from users of the QuitCoach. QuitCoach users complete a 10-minute assessment of their smoking and quit intentions and on this basis receive a detailed personalised quit plan. We will be recruiting via a question inserted into the QuitCoach assessment, on interest in participating in a study designed to improve the program and to better understand what determines the likelihood of quit attempts succeeding. Randomization is via a hidden binary number generator in the on-line recruitment survey. Following randomization this the questionnaire varies somewhat, including most of the elements of the Immediate Implementation arm and some elements of the Structured Planning arm which are delivered to those eligible. Participants know what they are receiving, but not about the alternatives.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is via a hidden binary number generator in the on-line recruitment survey which is activated after the person consents, allocating a code of 0 or 1 for each arm of the study (i.e., 0,0 = neither immediate implementation nor structured planning; 0,1 = no immediate implementation, receiving structured planning; 1,0 = receiving recommendation to quit immediately but no structured planning; 1,1 = receiving both interventions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Logistic regression was used to test the overall 3×2 treatment group comparison, including each study arm main effect and the interaction term. Outcomes were thereafter assessed separately for each study arm using simple chi-squared tests, complemented by logistic regressions controlling for baseline variables and any main effects or interactions of the other study arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2012
Actual
22/05/2012
Date of last participant enrolment
Anticipated
Actual
14/07/2013
Date of last data collection
Anticipated
Actual
14/07/2014
Sample size
Target
2400
Accrual to date
Final
2565
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 285332 0
Government body
Name [1] 285332 0
National Health and Medical Research Council (NHMRC)
Country [1] 285332 0
Australia
Primary sponsor type
Individual
Name
Ron Borland
Address
Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 284185 0
Individual
Name [1] 284185 0
James Balmford
Address [1] 284185 0
Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country [1] 284185 0
Australia
Other collaborator category [1] 260827 0
Individual
Name [1] 260827 0
Elena Swift
Address [1] 260827 0
Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country [1] 260827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287345 0
Cancer Council Victoria Human Research Ethics Committee
Ethics committee address [1] 287345 0
Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3053
Ethics committee country [1] 287345 0
Australia
Date submitted for ethics approval [1] 287345 0
Approval date [1] 287345 0
01/03/2011
Ethics approval number [1] 287345 0
1108

Summary
Brief summary
It is currently unclear whether there is a benefit for smokers to act immediately on impulses to quit smoking, and if so, whether delay is detrimental in its own right, or only if the time is not used productively for appropriate planning. It is also unclear whether planning can effectively be carried out after quitting, allowing smokers to quit spontaneously yet still effectively plan for the maintenance of their attempt. The study is designed to untangle these issues, specifically exploring the benefit of structured support and the possible positive effects of recommending immediate implementation, apart from any delay required by the help to be used (e.g., medications that need to be used for a period before quitting).

We hypothesize that among smokers who seek help, 6-month sustained abstinence assessed on an intention-to-treat basis will be greater among:
1. Those encouraged to quit immediately as compared with those encouraged to quit to their own timetable;
2. Those who are provided with a structured planning program based around the development of implementation intentions (if-then statements designed to increase the likelihood that a goal is attained), as compared with those only provided motivational messages and general encouragement to plan;
3. And that these two effects will be independent.
We will also explore the outcomes as a function of compliance with the recommended strategies, and whether the trial outcomes differ for different outcome measures (e.g. point-prevalence cessation, different imputation strategies for dealing with missing cases).
Trial website
Trial related presentations / publications
Borland, R., Balmford, J., Swift, E. (2015). Effects of encouraging rapid implementation and/or structured planning of quit attempts on smoking cessation outcomes: A randomized controlled trial. Annals of Behavioral Medicine, 49, 732-42.

Balmford, J., Borland, R., Swift, E. (2014). Planning, timing and quit success: A randomised controlled trial. 13th International Congress of Behavioral Medicine, Groningen, Netherlands, August 20-23.

Borland, R., Balmford, J., Swift, E. (2014). Effects of timing of initiation and planning on smoking cessation outcomes: A randomised controlled trial. Society for Research on Nicotine and Tobacco Annual Meeting (SRNT), Seattle, February 5-8.
Public notes

Contacts
Principal investigator
Name 34235 0
Prof Ron Borland
Address 34235 0
Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004
Country 34235 0
Australia
Phone 34235 0
+61 3 9514 6291
Fax 34235 0
Email 34235 0
[email protected]
Contact person for public queries
Name 17482 0
Prof Ron Borland
Address 17482 0
Cancer Council Victoria, 1 Rathdowne St, Carlton, VIC, 3053
Country 17482 0
Australia
Phone 17482 0
+61 3 9635 5185
Fax 17482 0
+61 3 9635 5440
Email 17482 0
[email protected]
Contact person for scientific queries
Name 8410 0
Prof Ron Borland
Address 8410 0
Cancer Council Victoria, 1 Rathdowne St, Carlton, VIC, 3053
Country 8410 0
Australia
Phone 8410 0
+61 3 9635 5185
Fax 8410 0
+61 3 9635 5440
Email 8410 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
EmbaseEffects of Encouraging Rapid Implementation and/or Structured Planning of Quit Attempts on Smoking Cessation Outcomes: a Randomized Controlled Trial.2015https://dx.doi.org/10.1007/s12160-015-9706-3
EmbaseThe association between the nature of the goal committed to and quitting smoking.2017https://dx.doi.org/10.1093/her/cyx066
N.B. These documents automatically identified may not have been verified by the study sponsor.