Condition category
Circulatory System
Date applied
27/11/2017
Date assigned
28/11/2017
Last edited
28/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Smoking remains the leading cause of preventable illness and death in England. Evidence shows that brief advice to stop smoking from a GP together with an immediate offer of support is effective at encouraging smokers to quit. Despite this, many people with smoking-related chronic illnesses continue to do so despite being repeatedly offered help to quit. For these ‘ hardcore’ smokers, alternative brief advice interventions need to be explored. Electronic cigarettes (‘e-cigarettes’) are increasingly used by smokers not seeking treatment, many of whom reduce smoking and stop without initially intending to do so. The aim of this study is to test an alternative approach to smoking management designed to support people who have a smoking-related illness reduce their smoking and quit.

Who can participate?
Adults aged 18 years or older who is a current smoker.

What does the study involve?
GPs and nurses receive online training on how to give a brief advice intervention to smokers who do not want to stop but have a smoking-related illness. Patients who are smokers with a long-term condition attend their usual annual review appointment of their condition, where the GP or nurse discuss their smoking. Those who decline referral to NHS stop smoking services (SSS) and smoking cession medication are randomly allocated to one of two groups. Those in the first group receive nothing beyond the usual care already provided. Those in the second group are given brief advice and an offer to try an e-cigarette with technical support provided from an online help forum and telephone call-back service run by experienced e-cigarette users. Consultations are audio-recorded to see how well GPs and nurses followed the training and which communication strategies worked well. Participants are interviewed after taking part to see how they felt about being assisted in this way by their GP or nurse. The study will look at whether more people stop or halve their smoking in the short-term.

What are the possible benefits and risks of participating?
Participants may benefit from reducing their smoking. There are no direct risks with participating.

Where is the study run from?
1. University of Oxford (UK)
2. University of Nottingham (UK)

When is the study starting and how long is it expected to run for?
November 2016 to October 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Rachna Begh
rachna.begh@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rachna Begh

ORCID ID

Contact details

UK Centre for Tobacco and Alcohol Studies
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
+44 1865 617191
rachna.begh@phc.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36562

Study information

Scientific title

Management of Smoking in primary Care: A randomised controlled trial on the effectiveness of GP/nurse promotion of e-cigarettes in supporting reduced smoking and abstinence in hardcore smokers with smoking-related chronic disease

Acronym

MaSC

Study hypothesis

The aim of this study is to examine the feasibility, acceptability and effectiveness of GP/nurse promotion of e-cigarettes to support smoking reduction and cessation in hardcore smokers with smoking-related chronic diseases.

Ethics approval

Wales Research Ethics Committee 4, 15/11/2017, ref: 17/WA/0352

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary care, Primary sub-specialty: Public Health; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs, Cardiovascular/ Pulmonary heart disease and diseases of pulmonary circulation, Respiratory/ Lung diseases due to external agents, Stroke/ Cerebrovascular diseases

Intervention

Smokers with a smoking-related chronic disease and who have no intention of stopping immediately or seeking cessation support are randomised to one of two groups if they decline referral to NHS stop smoking services (SSS) and smoking cessation medication during a routine annual review appointment with their GP or Practice Nurse: an intervention group offered encouragement by their practitioner to use an e-cigarette, or a standard care control group who will receive nothing beyond the usual care already provided prior to randomisation.

Participants in the intervention group are offered an e-cigarette starter pack and accompanying practical support booklet, containing links to a telephone call back service for technical support and a dedicated study-website. Participants are followed-up at two months and eight months after their annual review appointment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. The first primary outcome is 7-day point-prevalence abstinence from smoked tobacco at two months. Abstinence is defined as complete self-reported abstinence from smoking – not even a puff – in the past seven days, accompanied by a salivary anabasine concentration of <1ng/ml.
2. The second primary outcome is reduction in cigarette consumption at two months. Reduction is defined as a 50% reduction in self-reported cigarettes per day on each of the last seven days at two months compared with baseline consumption, accompanied by evidence of reduced smoke intake indicated by salivary anabasine concentrations lower than baseline.

Secondary outcome measures

Secondary outcome measures for abstinence include 7-day point prevalence abstinence measured at eight months, biochemically confirmed by an exhaled CO of <10 ppm. Six-month prolonged abstinence will be measured using the Russell standard criteria, defined as smoking fewer than five cigarettes between two and eight month follow-ups, confirmed by an anabasine concentration of <1ng/ml at two months and an exhaled CO concentration of <10ppm at eight months.

Overall trial start date

01/11/2016

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Aged 18 years or above
3. Current smoker with a value of at least 10 parts per million (ppm) for exhaled carbon monoxide (CO)
4. Diagnosed with one or more of the following chronic conditions: ischaemic heart disease, peripheral vascular disease, hypertension, diabetes mellitus (Type 1 and Type 2), stroke, asthma, COPD, chronic kidney disease, depression, schizophrenia, bipolar disorder or other psychoses

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 320; UK Sample Size: 320

Participant exclusion criteria

1. GP believes that switching to e-cigarettes would not benefit the patient given their current medical condition
2. Currently using e-cigarettes, nicotine replacement therapy or non-nicotine based cessation therapies (e.g. bupropion, nortriptyline or varenicline)
3. Plans to stop smoking before or at the annual review
4. Currently enrolled in another smoking-related study or other study where the aims of the studies are incompatible
5. Cannot consent due to mental incapacity
6. Pregnant, breastfeeding or planning to become pregnant during the course of the study

Recruitment start date

22/01/2018

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX2 6GG
United Kingdom

Trial participating centre

University of Nottingham
Division of Primary Care Tower Building University Park
Nottingham
NG7 2RD
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2020. Study protocol to be submitted in a peer reviewed journal in 2018 and will be available online.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rachna Begh, rachna.begh@phc.ox.ac.uk.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes