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Trial registered on ANZCTR

Registration number

ACTRN12619000032156

Ethics application status

Approved

Date submitted

30/12/2018

Date registered

11/01/2019

Date last updated

16/11/2023

Date data sharing statement initially provided

11/01/2019

Date results provided

16/11/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Stop for the Op and stop for life; Can smoking cessation be increased before elective-surgery by an offer of free mailed nicotine replacement therapy (NRT) and Quitline counselling to smokers waiting for surgery?

Scientific title

Reducing cardiovascular risk through smoking cessation before elective surgery. A randomized control trial of mailed nicotine replacement therapy (NRT) and behavioural support and relapse-prevention.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1226-1173

Trial acronym

Linked study record

This is an extension study of pilot trial ACTRN12616000073404

Health condition

Health condition(s) or problem(s) studied:

tobacco use

cardiovascular risk

elective surgery

Condition category

Condition code

Public Health

Health service research

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomised controlled trial of uptake, use and smoking cessation outcomes after an offer of smoking cessation help in adult elective surgery patients who smoke, compared to standard care. Intervention group smokers receive an invitation, pre-surgery, when name is placed on the elective-surgery wait-list for free nicotine replacement therapy (NRT) mailed to their home, printed quit information and enrollment in Quitline call-back service for telephone support. The intended use is for assistance with pre-surgical quitting. The dose of NRT will vary according to nicotine dependence (a) Highly dependent (smokes >15/day): 5-weeks of NRT patches, reducing dose regimen as follows: Size, 21-mg/worn for 24-hrs, changed daily, duration of use=3 weeks, then size 14-mg/worn for 24hrs, changed daily, duration of use=1 week then size 7-mg/worn for 24hrs, changed daily, duration of use=1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (b) Moderately dependent (10-15/day): 3-weeks of patches, size 14-mg/worn for 24/hrs, changed daily, duration=2 weeks, followed by size 7-mg/worn for 24hrs, changed daily, duration =1 week, PLUS 2mg nicotine lozengers, to be used in conjunction with patches if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. (c)Light/intermittent/social (<10/day): No patches, 2mg nicotine lozengers, to be used if cravings occur, maximum 7 lozengers per day, supply of 72 lozengers. Participants in intervention group may request the NRT products at any time prior to their operation date, including an additional course of treatment if the initial products posted did not achieve smoking abstinence prior to surgery. The additional printed information sent to smokers in the intervention group prior to surgery is an existing Quitline resource, https://www.quit.org.au/documents/231/AQ710_Smoking_and_Surgery_DL_update_v5.pdf
Participants quit by surgery for >24 hours will be offered a "Relapse Prevention Kit" on day of operation for use after hospital discharge. This consists of further 2mg NRT lozengers, to be used if cravings occur after hospital discharge, and printed relapse prevention advice. This printed advice will be existing Quitline resources:
https://www.quit.org.au/131/download
https://www.quit.org.au/385/download

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Usual care (consists of a mailed brochure containing information about smoking and surgery and advice to seek Quitline support). This is a standard Peninsula Health brochure, sent to all smokers having elective surgery and available at: https://www.peninsulahealth.org.au/wp-content/uploads/Important-advice-for-smokers.pdf

Control group

Active

Outcomes

Primary outcome [1]

Smoking cessation for >24 hours, confirmed by exhaled carbon monoxide level or 8 parts per million or less , using a calibrated hand held piCO+ Smokerlyzer (Bedfont Scientific, Maidstone, Kent, UK).

Timepoint [1]

Day of surgery

Secondary outcome [1]

Self-reported quit at least 4-weeks before surgery (if >4-weeks available between wait-listing and operation), determined using a study-specific questionnaire.

Timepoint [1]

Day of surgery

Secondary outcome [2]

Quit attempts while on wait-list for surgery (duration of each attempt and time before surgery that quit attempt ended), determined using a study-specific questionnaire

Timepoint [2]

Days on elective surgery wait-list

Secondary outcome [3]

Contact with Quitline during time on wait-list, including total number of contacts, determined using a study-specific questionnaire

Timepoint [3]

By day of surgery

Secondary outcome [4]

Self-reported 7-day point prevalence abstinence, assessed by phone call to participants after surgery. "Have you smoked at all in the last 7 days (even a puff)?"

Timepoint [4]

3-months after surgery

Eligibility

Key inclusion criteria

Any smoker
Having elective surgery
Available for data collection on day of surgery

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Unable to understand study requirements
2. Age<18
3. Weight <45 kg (from preop HQ)
4.Pregnancy or breastfeeding
5. Contraindication to nicotine patch. eg allergy
6. Already on stop-smoking medication
7. No phone
8. Emergency surgery
9. Not available for data collection on day of surgery.

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)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Stratified randomisation based on daily amount smoked prior to surgery, using a computerised random number generator; (https://www.randomizer.org). Allocations to either Intervention or Control groups will be concealed in opaque, numbered envelopes. 3 strata:
1-9 cigarettes a day
10-15 cigarettes a day
>15 cigarettes a day

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

1:1 randomisation within each strata based on amount smoked to intervention or control

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Given likely 10% abstinent in Control and 20% Intervention group from pilot ACTRN12616000073404 , 199 participants per group required, 5% significance level and 80% power. 20% additional subjects will be added to account for drop-out/loss-to-follow-up/never had their operation etc. Categorical data (quit/not quit etc) will be compared in contingency tables, Fishers exact test will used to determine significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/03/2019

Actual

1/04/2019

Date of last participant enrolment

Anticipated

1/04/2020

Actual

30/04/2020

Date of last data collection

Anticipated

30/07/2020

Actual

7/08/2020

Sample size

Target

480

Accrual to date

Final

516

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Foundation

Address [1]

Heart Foundation, Level 2, 850 Collins Street, Docklands VIC 3008

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Ashley Webb

Address

Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health HREC

Ethics committee address [1]

C/O Research Office
Frankston Hospital
Hastings Rd Frankston VIC 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/12/2018

Approval date [1]

25/03/2019

Ethics approval number [1]

HREC/49484/PH-2019

Summary

Brief summary

Over 20,000 Australians die each year from smoking. Such deaths are cardiovascular related in almost 40%. Even having a few cigarettes a day doubles risks of a heart attack. Quitting sharply reduces risks within a year or two, and is the best thing you can do for your heart.
Each year, large numbers of smokers have planned (elective) surgery for both vascular and non-vascular reasons. Promising evidence shows that offers of quit-help are particularly effective at this time in encouraging permanent quitting.
This will be the first study to evaluate the effect of a tailored quit intervention for all smokers (light and heavy) having elective surgery. The intervention will be offered weeks/months before surgery when the smoker is first put on the waiting list, as this gives more time for quitting and gets hearts and lungs in better shape for surgery. The intervention will be fast-acting Nicotine Replacement Therapy (NRT) lozengers, plus patches (for heavier smokers), and the tailored supply will be posted to acceptors of the offer. The telephone Quitline will provide extra support while quitting.
According to our existing data, relapse to daily smoking after hospitalisation for surgery occurs in 50% of newly abstinent smokers. This will also be the first study to evaluate a relapse prevention strategy for new quitters after having surgery. The relapse kit “Open in case of smoking emergency” will contain advice, phone numbers and fast-acting NRT. The use and effectiveness of the kit in protecting new abstinence will be studied 3-months after surgery.
This study builds on previous work by us that mailed NRT before planned surgery is feasible and increases quitting. By including all smokers, tailored NRT dosing, and a relapse kit, we hope to offer an effective low-cost intervention that any health service could adopt for the many smokers who have surgery. If more Australians give up smoking for good, heart attacks, blocked blood vessels and strokes will be prevented.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Ashley Webb

Address

Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 397847445

Fax

awebb@phcn.vic.gov.au

Contact person for public queries

Name

ASHLEY WEBB

Address

Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 397847445

Fax

webbx7@bigpond.com

Contact person for scientific queries

Name

Ashley Webb

Address

Department of Anaesthesia & Acute Pain Management
Frankston Hospital
Hastings Rd
Frankston VIC 3199

Country

Australia

Phone

+61 397847445

Fax

awebb@phcn.vic.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

IPD sharing resources and policies do not exist within Peninsula Health

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	Offering mailed nicotine replacement therapy and Quitline support before elective surgery: a randomised controlled trial.	2022	https://dx.doi.org/10.5694/mja2.51453

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