Plain English Summary
Background and study aims
Cigarette smoking is one of the biggest causes of illness and death in the UK. Smoking is extremely addictive, and it can be very difficult to give up. There are many systems in place to try and help people to quit smoking, including within the NHS. These can be very successful, as about half of the people who go to NHS Stop Smoking Clinics manage to successfully stop smoking after several weeks. Unfortunately, many people start smoking again within one year of quitting, and so more resources are needed to help people remain smoke-free. Self-help materials, such as education booklets or online resources, have proven to be very effective for people with a range of different problems. Studies have shown that specially designed self-help materials can help to reduce the number of people who start smoking again after quitting. The aim of this study is to find out if a set of eight educational booklets (called Forever Free) could help more people to remain non-smokers after using NHS Stop Smoking Services.
Who can participate?
Adults who have successfully quit smoking for four weeks.
What does the study involve?
Participants are randomly allocated into one of two groups. Participants in the first group (intervention group) are sent a letter and the set of eight “Forever Free” booklets. The first booklet contains a summary of the issues related to quitting smoking, and the remaining seven booklets provide more detailed information about the issues covered in the first booklet. Participants in the second group (control group) are sent a letter and a leaflet that is currently used in the NHS Norfolk Stop Smoking service. All participants are interviewed over the telephone after three months and then again after 11 months to find out whether they are managing to stay smoke-free. After one year, participants are given a breath test to confirm whether they have successfully stopped smoking long-term.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Norwich Medical School (UK)
When is the study starting and how long is it expected to run for?
June 2011 to May 2014
Who is funding the study?
National Institute for Health Research – Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Fujian Song
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fujian Song
ORCID ID
Contact details
Norwich Medical School
Faculty of Medicine and Health Sciences
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
+44 (0)160 359 1253
fujian.song@uea.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 09/91/36, v2, 07/04/2011
Study information
Scientific title
A randomised controlled trial of self-help materials for the prevention of smoking relapse
Acronym
SHARPISH
Study hypothesis
The study hypothesis is that the intervention, if effective, will improve abstinence rates, reduce repeated use of stop smoking services and might reduce use of other health care.
Ethics approval
Essex 1 REC, East of England REC Office 1, 20/04/2011, ref: 11/EE/0091
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Smoking addiction
Intervention
The study has two equal groups: one intervention and a control, each with 700 participants. Participants are people who stop smoking after treatment for 4 weeks in an NHS Stop Smoking clinics. Stop smoking advisors will give the Patient Information Sheet to all clients who attend their Stop Smoking Clinics.
The stop smoking advisors will again explain the trial to successful 4week quitters, answer questions, and invite those eligible, and interested, to participate in the trial and then take informed consent. All participants will then complete the baseline questionnaire.
The participants' paperwork will then be sent to the study researchers, at the University of East Anglia, where participants will be randomised (using a computerised allocation system). The intervention group will be sent a letter and the experimental intervention, which is a set of eight booklets designed to help prevent smoking relapse (called Forever Free). Booklet one is a summary of all issues, including an introduction of nicotine dependence, stages of smoking cessation, situations that are high risk for relapse, ways of coping with urges to smoke, and ways to handle an initial slip. The remaining seven booklets provide more extensive information on important issues for relapse prevention.
The control group will be sent a letter and the leaflet currently in use in NHS Norfolk Stop Smoking service (called Learning to Stay Stopped).
At two and eleven months following randomisation, a researcher will telephone all participants to assess the receipt, liking and use of the booklets, and also assess the key skills the manuals are trying to teach. At the final follow-up point, those people who report themselves as smoke-free, will be invited into the University of East Anglia to have this verified by CO-testing (expenses paid and £20 shopping voucher given in thanks).
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Prolonged abstinence from smoking between 4 -12 months. This will be confirmed by carbon monoxide, which can be considered as an objectively assessed outcome.
Secondary outcome measures
1. 7-day self-report point prevalence abstinence at 3 months and
2. 7-day biochemically confirmed point prevalence abstinence at 12 months
3. EQ-5D
4. Use of resources and mediating variables
Overall trial start date
01/06/2011
Overall trial end date
31/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Carbon monoxide (CO)-verified quitters at 4 weeks in the NHS stop smoking clinic
2. Can read English and sign the consent form to participate in the trial
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1400
Participant exclusion criteria
1. Pregnancy
2. From families in which one member has already been included in the study
3. Unable to read the educational material in English
Recruitment start date
01/06/2011
Recruitment end date
31/05/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East Anglia
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia (UK)
Sponsor details
c/o Miss Tracy Moulton
Research Contracts Manager
The Registry and Council House
Norwich
NR4 7TJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22647290
2015 secondary analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/26152558
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26218035
2017 process evaluation in: http://www.ncbi.nlm.nih.gov/pubmed/28334958
Publication citations
-
Protocol
Song F, Holland R, Barton GR, Bachmann M, Blyth A, Maskrey V, Aveyard P, Sutton S, Leonardi-Bee J, Brandon TH, Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial., Trials, 2012, 13, 69, doi: 10.1186/1745-6215-13-69.
-
Results
Song F, Maskrey V, Blyth A, Brown TJ, Barton GR, Aveyard P, Notley C, Holland R, Bachmann MO, Sutton S, Brandon TH, Differences in longer-term smoking abstinence after treatment by specialist or non-specialist advisors - secondary analysis of data from a relapse prevention trial, Nicotine Tob Res, 2015, doi: 10.1093/ntr/ntv148.
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Results
Blyth A, Maskrey V, Notley C, Barton GR, Brown TJ, Aveyard P, Holland R, Bachmann MO, Sutton S, Leonardi-Bee J, Brandon TH, Song F, Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial, Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial, 2015 , 19, 59, 1-70.