A randomised controlled trial of self-help materials for the prevention of smoking relapse (SHARPISH)
NHS Stop Smoking Clinics help people stop smoking. About half the people who go to the clinics have stopped smoking by the end of the four weeks. However, about seven out of ten people who have stopped smoking for four weeks, start to smoke again within one year.
In America, people who had already stopped smoking were given a set of self-help booklets. The booklets gave advice on how not to start smoking again and new ways to behave. People who used these booklets had a much better chance of remaining non-smokers. If the books were used in the UK, more people might be able to give up smoking for good.
We want to test this idea by using these booklets in England. People who have managed to stop smoking for four weeks will be asked if they want to take part. Those who say yes will be put into one of two groups at random (as if "by the toss of a coin"). People in group 1 will be sent one self help booklet that is used now in the NHS. People in group 2 will be sent the new self-help booklets.
Three months and 12 months after people have given up smoking, we will phone (or contact them by post) to ask whether or not they have started smoking again. We will also ask their opinion on the self-help booklets. At 12 months, we will invite those who are still not smoking to have a breath Carbon-Monoxide test which confirms they have stopped smoking. When the study comes to an end, we will be able to find out whether the new self-help booklets can help more people stop smoking.
The SHARPISH study started in June 2011 and is due to run for 36 months. This study is being run by the University of East Anglia with funding from the NIHR Health Technology Assessment Programme.
Design: Randomised controlled trial. The recruitment of participants will occur before the random allocation. The random allocation will be carried out by using a computerised allocation system. This will be an open trial, without attempts to blind investigators and patients after randomisation.
Setting: We will recruit four-week quitters from NHS Stop Smoking (SS) clinics, General Practices, pharmacies and Health Trainer services. The investigated self-help educational material will be sent to trial participants for their use at home.
Sample size: 1,400 quitters will be included in total (700 in each arm).
Target population: Biochemically verified 4-week quitters, defined as a treated smoker who self-reports continuous abstinence from day 14 post-quit date to the 4-week follow-up point and with a CO-reading of less than 10 ppm.
Interventions investigated: The experimental intervention tested in the proposed trial is a set of 8 Forever FreeTM booklets. Booklet 1 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 7 booklets provide more extensive information on important issues for relapse prevention. The original Forever FreeTM booklets were prepared for users in the United States. We will revise and update the booklets to make the material more suitable to British users and the UK NHS. The control intervention will be a smoking cessation booklet currently used in the NHS.
Measurement of cost and outcomes: The primary outcome will be prolonged abstinence from months 4-12 with no more than 5 lapses, confirmed by CO less than 10 ppm at 12 months. The secondary outcomes will be point 7-day self-report point prevalence abstinence at 3 months and 7-day biochemically confirmed point prevalence abstinence at 12 months. We will also collect information on amount of time spent on reading the received booklets, perceived benefit of self-help materials in terms of changes in motivation and acquisition of coping skills, capability of identifying situations in which the risk of smoking relapse is high, and the actual use of coping skills in high risk situations. Utility will be measured using the EQ-5D. Costs considered will include resources required for self-help materials, repeated use of stop smoking services, smoking cessation medication, GP visits, and hospitalisation.
Fujian Song, Richard Holland, Garry R Barton, Max Bachmann, Annie Blyth, Viv Maskrey, Paul Aveyard, Stephen Sutton, Jo Leonardi-Bee and Thomas H Brandon. 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.
Link to full study protocol:
SHARPISH Trial Numbers
UKCRN ID number.
Link to HTA web page for study:
This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 09/91/36). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR or the Department of Health.