Condition category
Mental and Behavioural Disorders
Date applied
25/07/2011
Date assigned
28/07/2011
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/099136
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0009/54756/PRO-09-91-36.pdf

Ethics approval

Essex 1 REC, East of England REC Office 1, 20/04/2011, REC 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 below 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 measures

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

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

Norwich Medical School
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

http://www.uea.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (09/91/36)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes