Condition category
Cancer
Date applied
13/07/2016
Date assigned
21/07/2016
Last edited
24/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation.

Trial website

Contact information

Type

Public

Primary contact

Ms Joanna Mitchell

ORCID ID

http://orcid.org/0000-0003-2138-3402

Contact details

Department of Public Health and Primary Care
Institute of Public Health
Forvie Site
University of Cambridge School of Clinical Medicine
Box 113
Cambridge Biomedical Campus
Cambridge
CB2 0SR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30934

Study information

Scientific title

Improving quit rates among smokers in primary care: Pragmatic trial of effectiveness and cost-effectiveness of a tailored web- and text message-based intervention for smoking cessation (iQuit in Practice)

Acronym

Study hypothesis

The aim of this study is to establish the effectiveness and cost-effectiveness of the iQuit in Practice intervention compared to routine care alone.

This study is a follow up study to a pilot study available via: http://www.isrctn.com/ISRCTN56702353

Ethics approval

East of England - Cambridge East Research Ethics Committee, 29/02/2016, ref: 16/EE/0030

Study design

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

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

Patients will be randomly allocated to either the control or intervention group during the consultation through the on-line iQuit software.

Control group: Participants receive usual care alone. This involves having a face to face discussion on reasons why a patient smokes and why they may want to quit; a breath test to measure CO and a discussion on stop smoking treatments that are available such as nicotine replacement therapies and Champix. Patients are also offered follow-up support and advice on how to avoid potential pitfalls that might get in the way of a successful quit attempt.

Intervention group: Participants receive the iQuit intervention. In addition to ‘usual care’ and the tailored report generated from the iQuit software, participants will begin to receive text messages the day before their quit date and 0, 1 or 2 messages each day for 90 days. The following are examples of text messages a participant might receive.

“Hi Sarah, welcome to iQuit in Practice, a personal program of quitting support. We hope you enjoy it and that it helps in your quit attempt. The iQuit team.”

“As well as removing cigarettes and ashtrays, ask any visitors not to smoke inside. Now's a great time to freshen up the curtains and wipe away any smoke stains.”

“Quitting is great for your skin. Several studies have found measureable improvements in the skin tone of quitters, often within in the first four weeks!”

“By staying quit, your immune system will start to recover, meaning you'll soon be better able to fight off colds and other illnesses.”

“After all your effort to get this far, make sure you reward yourself. It's a real achievement, and this time it's for good. :-)”

“Don't believe 'just one' is okay: A 2010 review found that even 'light' smokers were at much more risk of lung problems and cataracts compared to non-smokers.”

“Hi Sarah, great job so far. Just make sure you don't give yourself any excuses. You decided to quit because you wanted to QUIT.”

Follow up is at 4 weeks and 6 months post quit date: Follow-up is a CO test (at 4 weeks), a questionnaire and saliva test (at 6 months).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Self-reported abstinence from smoking for 6 months endorsed by biochemical verification measured 6 months after the participant’s quit date. Abstinence from smoking will be measured 6 months after the participant’s quit date using a questionnaire (sent by the research team) followed by biochemical verification. All participants that have stated in the questionnaire they have not smoked for 6 months will be sent a kit to collect a saliva sample. The sample will be analysed for cotinine (a nicotine metabolite). If the sample is positive for cotinine then the sample will also be assayed for anabasine to differentiate whether the cotinine has come from tobacco, E-Cig or NRT.

Secondary outcome measures

1. Abstinence is measured using carbon monoxide (CO) testing at baseline and the routine follow-up 4-week appointment in the patient’s GP practice
2. Abstinence is measured through self-reporting using a questionnaire deigned for this study at 6 months (not biochemically validated)
3. Cost-effectiveness of the intervention is determined using a questionnaire at 6 months post quit date will determine NHS costs accumulated during the previous 6 months through questions on GP visits and medications prescribed, including NRTs

Overall trial start date

11/07/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Current smoker aged 16 - 75
2. Wants to quit and willing to attending for smoking cessation support at a GP practice
3. Owns a mobile phone and familiar with sending/receiving text messages
4. Able to read and understand English, and give informed written consent
5. Willing to set a quit-date within 14 days of starting the study
6. Not currently involved in another formal smoking cessation study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1452; UK Sample Size: 1452

Participant exclusion criteria

1. Not meeting the inclusion criteria
2. Their GP feels that it would not be appropriate for them to participate (e.g. severe complex additional health problems)

Recruitment start date

11/07/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Alconbury and Brampton Surgery
School Lane Alconbury
Huntingdon
PE28 4EQ
United Kingdom

Trial participating centre

Cathedral Medical Centre
Princess of Wales Hospital Kilkenny Avenue Lynn Road
Ely
CB6 1DN
United Kingdom

Trial participating centre

The Riverside Practice
23 Marylebone Road
March
PE15 8BG
United Kingdom

Trial participating centre

Prospect Medical Practice
95 Aylsham Road
Norwich
NR3 2HW
United Kingdom

Trial participating centre

Hanscombe House Surgery
52A St Andrew Street
Herford
SG14 1JA
United Kingdom

Trial participating centre

The Cornerstone Practice
Elwyn Road
March
PE15 9BF
United Kingdom

Trial participating centre

The Old Exchange
East Street
St. Ives
PE27 5PB
United Kingdom

Trial participating centre

Sawston Medical Centre
London Road
Sawston
CB22 3HU
United Kingdom

Trial participating centre

The Peninsula Practice
Mill Hoo
Alderton
IP12 3DA

Trial participating centre

Mundesley Medical Centre
Munhaven Close Mundesley
Norwich
NR11 8AR
United Kingdom

Trial participating centre

Beccles Medical Centre
St. Mary's Road
Beccles
NR34 9NX
United Kingdom

Trial participating centre

Fakenham Medical Practice
Meditrina House Trinity Road
Fakenham
NR21 8SY
United Kingdom

Trial participating centre

Wellside Surgery
45 High Street Sawtry
Huntingdon
PE28 5SU
United Kingdom

Trial participating centre

Welland Medical Practice
142 Eye Road
Peterborough
PE1 4SG
United Kingdom

Trial participating centre

Feltwell Surgery
Old Brandon Road
Feltwell
IP26 4AY
United Kingdom

Trial participating centre

Oak Street Medical Practice
Oak Street
Norwich
NR3 3DL
United Kingdom

Trial participating centre

Hingham Surgery
Hardingham Street
Hingham
NR9 4JB
United Kingdom

Trial participating centre

The Maples Health Centre
Vancouver Road
Broxbourne
EN10 6FD
United Kingdom

Trial participating centre

The Chesterfield Drive Practice
29 Chesterfield Drive
Ipswich
IP1 6DW
United Kingdom

Trial participating centre

Grove Surgery
Grove lane
Thetford
IP24 2HY
United Kingdom

Trial participating centre

Hoveton and Wroxham Medical Practice
Stalham Road
Hoveton
NR12 8DU
United Kingdom

Trial participating centre

Kirkley Mill Surgery/Falkland Surgery
Clifton Road
Lowestoft
NR33 0HF
United Kingdom

Trial participating centre

Leighton Road Surgery
1 Leighton Road
Leighton Buzzard
LU7 1LB
United Kingdom

Trial participating centre

Flitwick Surgery
Highlands
Flitwick
MK45 1DZ
United Kingdom

Trial participating centre

Greensands Surgery
The Health Centre Oliver Street
Ampthilll
MK45 2SB
United Kingdom

Trial participating centre

Pemberley Surgery
32 Pemberley Avenue
Bedford
MK40 2LA
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Addenbrooke's Hospital
Box 111
Hills Road
Cambridge
CB2 0SP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The main papers to come out from this trial will be the protocol paper and trial results. Recruitment and follow-up is expected to be complete by the autumn of 2019 with trial publications being published in early 2020. At around this time it is expected that findings will also be presented at academic conferences and GP research forums.

Intention to publish date

31/03/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review