ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

Lifestyle

Comparator / control treatment

Active control – standard treatment (public version of QuitCoach program and associated resources)

Control group

Active

Outcomes

Primary outcome [1]

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]

TP: 6 months after quit date

Secondary outcome [1]

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]

The initial (2-week) follow-up

Secondary outcome [2]

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]

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

National Health and Medical Research Council, GPO Box 1421, Canberra ACT 2601, Australia.

Country [1]

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]

Individual

Name [1]

James Balmford

Address [1]

Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Elena Swift

Address [1]

Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cancer Council Victoria Human Research Ethics Committee

Ethics committee address [1]

Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3053

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/03/2011

Ethics approval number [1]

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

Prof Ron Borland

Address

Cancer Council Victoria, 615 St Kilda Rd, Melbourne VIC 3004

Country

Australia

Phone

+61 3 9514 6291

Fax

Ron.Borland@cancervic.org.au

Contact person for public queries

Name

Ron Borland

Address

Cancer Council Victoria, 1 Rathdowne St, Carlton, VIC, 3053

Country

Australia

Phone

+61 3 9635 5185

Fax

+61 3 9635 5440

Ron.Borland@cancervic.org.au

Contact person for scientific queries

Name

Ron Borland

Address

Cancer Council Victoria, 1 Rathdowne St, Carlton, VIC, 3053

Country

Australia

Phone

+61 3 9635 5185

Fax

+61 3 9635 5440

Ron.Borland@cancervic.org.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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of Encouraging Rapid Implementation and/or Structured Planning of Quit Attempts on Smoking Cessation Outcomes: a Randomized Controlled Trial.	2015	https://dx.doi.org/10.1007/s12160-015-9706-3
Embase	The association between the nature of the goal committed to and quitting smoking.	2017	https://dx.doi.org/10.1093/her/cyx066

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically