Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)

Tobacco Smoking Clinical Trial

— PORTSSS  

Official title:

Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775944
• Other study ID #: 08118
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2008
• Last updated: September 26, 2012
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2012
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study shall determine whether or not proactive telephone support for smoking cessation delivered to quitline callers is more effective than standard 'reactive' provision and whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy (NRT) has any additional impact on smoking cessation rates achieved by behavioural interventions.

Description:

There is evidence from other studies that telephone helplines are effective in helping individuals to stop smoking. This study will investigate whether or not two interventions that have been proven effective in other contexts are effective when offered via telephone helplines. The two interventions which will be tested are (1) additional proactive counselling via telephone(several calls from a trained smoking cessation advisor over a certain period) and (2) the offer of Nicotine Replacement Therapy.

This trial will determine whether or not: (1)additional (proactive) telephone support for smoking cessation delivered to users of the National Health Service (NHS)Smoking Helpline, is more effective than standard support given by the helpline, and (2) whether the offer of free Nicotine Replacement Therapy influences rates of stopping smoking in individuals receiving either standard (reactive) or proactive telephone support.

Current smokers over 16 years of age will be recruited by helpline staff with the appropriate consent. Participants will then be randomised into one of four groups:

(i) usual care delivered by the helpline (called the Together Programme) (ii) usual care plus a programme of proactive telephone counselling (iii) usual care AND the offer of Nicotine Replacement Therapy (NRT) (iv) usual helpline support, proactive telephone counselling AND the offer of NRT.

The researchers will not be aware of which group participants have been allocated. The results will determine if the use of proactive telephone counselling is effective in helping individuals to stop smoking. It shall also find out if the offer of NRT medication via a telephone helpline assists individuals in their efforts to stop smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2591
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Participants are over 16 and will need to agree to i) receive counselling ii) to set a quit within two weeks and iii) consent to follow up processes.

Exclusion Criteria:

• Telephonists will not enrol potential participants who are not capable of giving informed consent or who have not got access to a phone contact number to which calls can be made by Essentia staff.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• Proactive telephone support
Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls.
• Reactive (standard) telephone support
Reactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it.

Drug:
• Offer of voucher for cost-free Nicotine Replacement Therapy
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Department of Health, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (16)

An LC, Schillo BA, Kavanaugh AM, Lachter RB, Luxenberg MG, Wendling AH, Joseph AM. Increased reach and effectiveness of a statewide tobacco quitline after the addition of access to free nicotine replacement therapy. Tob Control. 2006 Aug;15(4):286-93. — View Citation

Ashenden R, Silagy C, Weller D. A systematic review of the effectiveness of promoting lifestyle change in general practice. Fam Pract. 1997 Apr;14(2):160-76. Review. — View Citation

Britton J, Lewis S. Trends in the uptake and delivery of smoking cessation services to smokers in Great Britain. J Epidemiol Community Health. 2004 Jul;58(7):569-70. — View Citation

Coleman T, Lewis S, Hubbard R, Smith C. Impact of contractual financial incentives on the ascertainment and management of smoking in primary care. Addiction. 2007 May;102(5):803-8. — View Citation

Edwards R, Coleman T. Going smoke-free: the medical case for clean air in the home, at work and in public places. Clin Med (Lond). 2005 Nov-Dec;5(6):548-50. — View Citation

Ferguson J, Bauld L, Chesterman J, Judge K. The English smoking treatment services: one-year outcomes. Addiction. 2005 Apr;100 Suppl 2:59-69. — View Citation

Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. Review. Update in: Cochrane Database Syst Rev. 2002;(1):CD000031. — View Citation

Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.

Pierce JP, White MM, Gilpin EA. Adolescent smoking decline during California's tobacco control programme. Tob Control. 2005 Jun;14(3):207-12. — View Citation

Platt S, Tannahill A, Watson J, Fraser E. Effectiveness of antismoking telephone helpline: follow up survey. BMJ. 1997 May 10;314(7091):1371-5. — View Citation

Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2002;(4):CD000146. Review. Update in: Cochrane Database Syst Rev. 2004;(3):CD000146. — View Citation

Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2000;(3):CD000146. Review. Update in: Cochrane Database Syst Rev. 2001;(3):CD000146. — View Citation

Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. Review. Update in: Cochrane Database Syst Rev. 2006;(3):CD002850. — View Citation

Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. Review. Update in: Cochrane Database Syst Rev. 2002;(3):CD001007. — View Citation

Tobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.

Tonstad S, Tønnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.	Prolonged abstinence was defined as not smoking between a quit date and six months later with minor smoking lapses permitted as long as no more than 5 cigarettes in total were smoked during this period.	6 months from participant's quit date	No
Secondary	Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.	The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.	Measured 6 months after participant's quit date	No
Secondary	Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months	Participants had to report not smoking in the three months prior to outcome ascertainment.	Measured at 6 months after participant's quit date	No
Secondary	Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month	Prolonged abstinence was defined as not smoking between a quit date and one month later; minor lapses were permitted provided no more than 5 cigarettes in total had been smoked.	Measured at 1 month after participant's quit date	No
Secondary	Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month	Participants had to report not smoking for 7 or more days prior to outcome ascertainment.	Measured at 1 month after participant's quit date	No
Secondary	Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months	As title	Measured 6 months after participant's quit date	No
Secondary	Health Status at 6 Months EuroQol 5D (EQ5D)	This is a generic measure of health status used in health economic analyses.	Measured 6 months after participant's quit date	No
Secondary	Use of Other NHS Smoking Cessation Interventions (e.g. Uptake of NHS Stop Smoking Services, Use of Other NRT Obtained From General Practitioner (GP) Etc.)	Participants' recall of the use they have made of other stop smoking interventions that are available through the National Health Service.	Measured 6 months after participant's quit date	No