Condition category
Not Applicable
Date applied
17/08/2018
Date assigned
04/10/2018
Last edited
27/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Several large studies have shown that the risk of cardiovascular (heart), respiratory (lung), and wound-healing complications (including death) within 30 days of surgery is greater for smokers than non-smokers. However, there is evidence that even short-term smoking cessation may reduce morbidity (illness) after surgery. Structural problems and scarcity of time and resources lead to patients at most Swedish surgical departments simply being told that they should quit, and perhaps being referred to a primary health care clinic. An SMS (text message)-based smoking cessation aid can be effective in helping individuals quit smoking, but is also a very simple and time efficient tool for surgical departments to administer. The aim of this study is to fill the knowledge gap on whether or not an SMS-based smoking cessation intervention can be effective at helping patients stop smoking before surgery. This study aims to assess the effectiveness of the SMS-based intervention on smoking behaviour as an additional tool on top of current routine treatment.

Who can participate?
Adult patients undergoing elective surgery

What does the study involve?
Participants are randomly allocated to one of two groups. One group is given access to the new SMS intervention, while the other group is not given access to the intervention. Both groups have access to the surgical departments’ current routine for smoking cessation before surgery. Smoking outcomes are measured through questionnaires after 3, 6, and 12 months.

What are the possible benefits and risks of participating?
This trial will collect data on the effectiveness of the intervention, increasing the evidence on SMS-based interventions for smoking cessation. One group is given a new intervention which is hoped to improve their chances of quitting smoking, but the researchers are not withholding any other treatment that individuals in the intervention or control group wish to use. All participants are free to use any service currently existing, but only the intervention group will receive the new intervention. There are therefore no immediate risks, but a potential benefit for patients that are allocated to the intervention group.

Where is the study run from?
20 surgical departments in south-east Sweden

When is the study starting and how long is it expected to run for?
September 2017 to October 2021

Who is funding the study?
Kamprad Family Foundation (Sweden)

Who is the main contact?
Dr Marcus Bendtsen

Trial website

http://www.nexit.nu/opr

Contact information

Type

Scientific

Primary contact

Dr Marcus Bendtsen

ORCID ID

http://orcid.org/0000-0002-8678-1164

Contact details

Linköping University
Linköping
58183
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Mobile phone-based smoking cessation intervention for patients with elective surgery – a randomised controlled trial

Acronym

NEXit OPR

Study hypothesis

Smoking cessation rates will be higher among individuals given access to a mobile phone-based intervention, compared to individuals without access.

Ethics approval

Regionala etikprövningsnämnden i Linköping: avdelningen för prövning av övriga forskning, 10/10/2018, dnr 2018/316-31

Study design

Two-arm parallel-group randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format

Condition

Smoking among patients with elective surgery

Intervention

All patients with elective surgery will be invited to the trial. One group will be given access to the mobile phone-based program delivered via SMS, including interactive component, while the other group will be told that they will not be given access to the intervention. Both groups will be told that they have access to the surgical departments’ current routine for smoking cessation prior to surgery. Smoking outcomes will be measured through questionnaires at 3, 6, and 12 months after randomisation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at 3, 6 and 12 months after randomisation using self-reported questionnaires:
1. Prolonged abstinence (not smoking more than 5 cigarettes the past 8 weeks). 8 weeks is adjusted to 5 and 11 months at 6- and 12-months follow-up
2. Point prevalence (not smoking any cigarette the past 4 weeks)

Secondary outcome measures

Measured at 3, 6 and 12 months after randomisation using self-reported questionnaires:
1. 7-day point prevalence (no cigarettes the past 7 days)
2. The number of quit attempts since joining the study
3. Number of cigarettes smoked per week (if still smoking)

Overall trial start date

01/09/2017

Overall trial end date

15/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All patients undergoing elective surgery will be invited to the trial (not children or neonatal)

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

434

Participant exclusion criteria

Not owning a mobile phone or non-smoker

Recruitment start date

15/10/2018

Recruitment end date

15/10/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

20 surgical departments in south-east Sweden
581 83
Sweden

Sponsor information

Organisation

The Kamprad Family Foundation for Entrepreneurship, Research & Charity

Sponsor details

Familjen Kamprads stiftelse
Västra Esplanaden 3
VÄXJÖ
352 30
Sweden

Sponsor type

Charity

Website

http://familjenkampradsstiftelse.se/in-english/

Funders

Funder type

Charity

Funder name

Familjen Kamprads Stiftelse

Alternative name(s)

Kamprad Family Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Sweden

Results and Publications

Publication and dissemination plan

A trial protocol will be submitted for review prior to the first patient being recruited. Data from the 3-month follow-up will be used to author an efficacy article regarding short-term effects in the beginning of 2020. Data from 6- and 12-month follow-up will be used to author an efficacy article regarding long-term effects in the beginning of 2022.

IPD sharing statement
Data will be archived on university servers. Due to GDPR the trialists are not allowed to hand over data.

Intention to publish date

01/01/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30912757 [added 27/03/2019]

Publication citations

Additional files

Editorial Notes

27/03/2019: Publication reference added. 16/10/2018: Ethics approval details added.