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

NCT00775944 | Completed Phase 4 Results

• 1 other identifier: 08118
• Study Type: interventional
• Target: 2,591
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Smoking

Keywords

Tobacco; Cigarette; Smoking; Counselling; Nicotine Replacement Therapy; Telephone; Quitline; Helpline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.

  Measured 6 months after participant's quit date

• Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months

  Measured at 6 months after participant's quit date

• Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month

  Measured at 1 month after participant's quit date

• Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 1 Month

  Measured at 1 month after participant's quit date

• Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months

  Measured 6 months after participant's quit date

Study Arms (4)

Standard support

ACTIVE COMPARATOR

Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment

Behavioral: Reactive (standard) telephone support

Proactive telephone support

ACTIVE COMPARATOR

Proactive support \& advice to obtain nicotine addiction treatment

Behavioral: Proactive telephone support

Standard support & offer NRT

ACTIVE COMPARATOR

Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy

Behavioral: Reactive (standard) telephone support; Drug: Offer of voucher for cost-free Nicotine Replacement Therapy

Proactive support & offer NRT

ACTIVE COMPARATOR

Proactive telephone support and offer of voucher for cost free NRT

Behavioral: Proactive telephone support; Drug: Offer of voucher for cost-free Nicotine Replacement Therapy

Interventions

Proactive telephone support BEHAVIORAL

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.

Also known as: Telephone, Counselling

Proactive support & offer NRT; Proactive telephone support

Reactive (standard) telephone support BEHAVIORAL

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.

Also known as: Together Programme

Standard support; Standard support & offer NRT

Offer of voucher for cost-free Nicotine Replacement Therapy DRUG

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

Also known as: NRT

Proactive support & offer NRT; Standard support & offer NRT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Department of Health, United Kingdom: collaborator

Study Sites (1)

University of Nottingham

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (19)

• Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2000;(3):CD000146. doi: 10.1002/14651858.CD000146.

  PMID: 10908462 BACKGROUND

• Tobacco Advisory Group of the Royal College of Physicians. Going smoke-free: The case for clean air in the home, at work and in public places. London: Royal College of Physicians of London, 2005.

  BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1093/fampra/14.2.160.

  PMID: 9137956 BACKGROUND

• Pierce JP, White MM, Gilpin EA. Adolescent smoking decline during California's tobacco control programme. Tob Control. 2005 Jun;14(3):207-12. doi: 10.1136/tc.2004.010116.

  PMID: 15923472 BACKGROUND

• Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.

  PMID: 11034670 BACKGROUND

• Tonstad S, Tonnesen 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. doi: 10.1001/jama.296.1.64.

  PMID: 16820548 BACKGROUND

• Ferguson J, Bauld L, Chesterman J, Judge K. The English smoking treatment services: one-year outcomes. Addiction. 2005 Apr;100 Suppl 2:59-69. doi: 10.1111/j.1360-0443.2005.01028.x.

  PMID: 15755262 BACKGROUND

• Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007.

  PMID: 10796582 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.1111/j.1360-0443.2007.01766.x.

  PMID: 17506157 BACKGROUND

• 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. doi: 10.1136/jech.2003.015271. No abstract available.

  PMID: 15194717 BACKGROUND

• Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. doi: 10.1002/14651858.CD002850.

  PMID: 12535442 BACKGROUND

• Platt S, Tannahill A, Watson J, Fraser E. Effectiveness of antismoking telephone helpline: follow up survey. BMJ. 1997 May 10;314(7091):1371-5. doi: 10.1136/bmj.314.7091.1371.

  PMID: 9161308 BACKGROUND

• 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. doi: 10.1136/tc.2005.014555.

  PMID: 16885577 BACKGROUND

• Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2002;(4):CD000146. doi: 10.1002/14651858.CD000146.

  PMID: 12519537 BACKGROUND

• Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  PMID: 39868569 DERIVED

• Ferguson J, Docherty G, Bauld L, Lewis S, Lorgelly P, Boyd KA, McEwen A, Coleman T. Effect of offering different levels of support and free nicotine replacement therapy via an English national telephone quitline: randomised controlled trial. BMJ. 2012 Mar 23;344:e1696. doi: 10.1136/bmj.e1696.

  PMID: 22446739 DERIVED

• Coleman T, McEwen A, Bauld L, Ferguson J, Lorgelly P, Lewis S. Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial. Trials. 2009 Apr 28;10:26. doi: 10.1186/1745-6215-10-26.

  PMID: 19400961 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Smoking

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Graeme Docherty
• Organization: University of Nottingham

graeme.docherty@nottingham.ac.uk

01158321380

Study Officials

• Tim Coleman, MB ChB

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 26, 2012
• Results First Posted: October 26, 2012

Record last verified: 2012-09

Locations

GB (1)