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| Name | Class |
|---|---|
| Department of Health, United Kingdom | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard support | Active Comparator | Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment |
|
| Proactive telephone support | Active Comparator | Proactive support & advice to obtain nicotine addiction treatment |
|
| Standard support & offer NRT | Active Comparator | Reactive telephone support (i.e. Together Programme) and 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Coleman, MB ChB | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nottingham | Nottingham | NG5 1PB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10908462 | Background | 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. | |
| 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. | ||
| 9137956 |
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Participants were recruited between February 2009 and January 2010. 2591 participants were randomised to one of the four treatment groups. Of these, 56 withdrew consent after being randomised and were not included in analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Support | Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment |
| FG001 | Standard Support & Offer of NRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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. |
|
|
| Offer of voucher for cost-free Nicotine Replacement Therapy | Drug | Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone |
|
|
Participants had to report not smoking in the three months prior to outcome ascertainment. |
| Measured at 6 months after participant's quit date |
| 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 |
| 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 |
| Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months | As title | Measured 6 months after participant's quit date |
| 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 |
| 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 |
| 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. |
| 15923472 | 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. |
| 11034670 | Background | Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031. |
| 16820548 | 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. |
| 15755262 | 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. |
| 10796582 | Background | Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007. |
| 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. |
| 17506157 | 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. |
| 15194717 | 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. |
| 12535442 | Background | Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. doi: 10.1002/14651858.CD002850. |
| 9161308 | 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. |
| 16885577 | 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. |
| 12519537 | 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. |
| 39868569 | Derived | 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. |
| 22446739 | 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. |
| 19400961 | 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. |
Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy
| FG002 | Proactive Telephone Support | Proactive support & advice to obtain nicotine addiction treatment |
| FG003 | Proactive Support & Offer of NRT | Proactive telephone support and offer of voucher for cost free NRT |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Support | Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment |
| BG001 | Proactive Telephone Support | Proactive support & advice to obtain nicotine addiction treatment |
| BG002 | Standard Support & Offer of NRT | Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy |
| BG003 | Proactive Support & Offer of NRT | Proactive telephone support and offer of voucher for cost free NRT |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomised cases | Posted | Number | participants | 6 months from participant's quit date |
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| 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. | Posted | Number | participants | Measured 6 months after participant's quit date |
| ||||||||||||||||||||||||||||||||||||||
| 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. | All randomised cases | Posted | Number | participants | Measured at 6 months after participant's quit date |
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| 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. | All randomised cases | Posted | Number | participants | Measured at 1 month after participant's quit date |
| |||||||||||||||||||||||||||||||||||||
| 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. | All randomised cases | Posted | Number | participants | Measured at 1 month after participant's quit date |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months | As title | Not Posted | Measured 6 months after participant's quit date | |||||||||||||||||||||||||||||||||||||||||
| Secondary | Health Status at 6 Months EuroQol 5D (EQ5D) | This is a generic measure of health status used in health economic analyses. | Not Posted | Measured 6 months after participant's quit date | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Measured 6 months after participant's quit date |
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Support | Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment | 0 | 0 | 0 | 0 | ||
| EG001 | Proactive Telephone Support | Proactive support & advice to obtain nicotine addiction treatment | 0 | 0 | 0 | 0 | ||
| EG002 | Standard Support & Offer of NRT | Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy | 0 | 0 | 0 | 0 | ||
| EG003 | Proactive Support & Offer of NRT | Proactive telephone support and offer of voucher for cost free NRT | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Graeme Docherty | University of Nottingham | 01158321380 | graeme.docherty@nottingham.ac.uk |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| 18-64 years |
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| >=65 years |
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| Unknown |
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| Male |
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| Unknown |
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