Tobacco SmokingPhase 4PORTSSSNCT00775944
Trial Comparing Different Methods of Support With Stopping Smoking (PORTSSS/Stop Together Trial)
A Phase 4 study testing Proactive telephone support, Reactive (standard) telephone support and Offer of voucher for cost-free Nicotine Replacement Therapy in people with Tobacco Smoking, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Proactive telephone support, Reactive (standard) telephone support and Offer of voucher for cost-free Nicotine Replacement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,591 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Sep 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
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.
Read the detailed 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.
- Conditions
- Tobacco Smoking
- Being tested
- Proactive telephone support, Reactive (standard) telephone support, Offer of voucher for cost-free Nicotine Replacement Therapy
- Keywords
- Tobacco, Cigarette, Smoking, Counselling, Nicotine Replacement Therapy, Telephone, Quitline, Helpline
- Medical subject headings
- Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive telephone supportBehavioural
Also called Telephone, Counselling
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 supportBehavioural
Also called Together Programme
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 TherapyDrug
Also called NRT
Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone
| Study group | Role | What they receive |
|---|---|---|
| Standard support | Active comparator | Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment Receives: Behavioral: Reactive (standard) telephone support |
| Proactive telephone support | Active comparator | Proactive support \& advice to obtain nicotine addiction treatment Receives: 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 Receives: 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 Receives: Behavioral: Proactive telephone support; Drug: Offer of voucher for cost-free Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The participant had to report not smoking for at least 7 days prior to the point of outcome assessment.
Measured: Measured 6 months after participant's quit date
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: 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: 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: 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: 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: 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: Measured 6 months after participant's quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,591 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Tim Coleman, MB ChB, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775944
- Sponsor's protocol ID
- 08118
- Acronym
- PORTSSS
- Status last verified
- Sep 2012
- First submitted
- 17 Oct 2008
- Last updated
- 26 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 10908462Tobacco 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.
Tobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.
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.
PubMed 9137956Pierce 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.
PubMed 15923472Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.
PubMed 11034670Tonstad 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.
PubMed 16820548Ferguson 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.
PubMed 15755262Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007.
PubMed 10796582Lancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.
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.
PubMed 17506157Britton 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.
PubMed 15194717Stead LF, Lancaster T, Perera R. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2003;(1):CD002850. doi: 10.1002/14651858.CD002850.
PubMed 12535442Platt 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.
PubMed 9161308An 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.
PubMed 16885577
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial Comparing Different Methods of Support With Stopping Smoking Offered Through The National Health Service (NHS) Smoking Helpline
- ClinicalTrials.gov ID
- NCT00775944
- Acronym / sponsor ID
- PORTSSS / 08118
- Conditions
- Tobacco Smoking
- Keywords
- Tobacco, Cigarette, Smoking, Counselling, Nicotine Replacement Therapy, Telephone, Quitline, Helpline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,591 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Department of Health, United Kingdom
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Posted 26 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard support | Active comparator | Behavioral: Reactive (standard) telephone supportStandard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment |
| Proactive telephone support | Active comparator | Behavioral: Proactive telephone supportProactive support \& advice to obtain nicotine addiction treatment |
| Standard support & offer NRT | Active comparator | Behavioral: Reactive (standard) telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement TherapyReactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy |
| Proactive support & offer NRT | Active comparator | Behavioral: Proactive telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement TherapyProactive telephone support and offer of voucher for cost free NRT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive telephone supportAlso: Telephone, CounsellingPro-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. | Behavioural | Proactive support & offer NRT, Proactive telephone support |
| Reactive (standard) telephone supportAlso: Together ProgrammeReactive counselling usually involves the provision of evidence-based information to support quit attempts without any or with only very brief counselling to accompany it. | Behavioural | Standard support, Standard support & offer NRT |
| Offer of voucher for cost-free Nicotine Replacement TherapyAlso: NRTOffer of voucher for cost-free Nicotine Replacement Therapy over the telephone | Drug | Proactive support & offer NRT, Standard support & offer NRT |
Primary outcome
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards.
Time frame: 6 months from participant's quit date
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.
7 secondary outcomes
Self-reported Point Prevalence Abstinence From Smoking for at Least 7 Days, Ascertained at 6 Months, With Carbon Monoxide (CO) Validation.
Time frame: Measured 6 months after participant's quit date
Self-reported Abstinence From Smoking for at Least Three Months, Ascertained at 6 Months
Time frame: Measured at 6 months after participant's quit date
Self-reported Prolonged Abstinence From Smoking Between a Quit Date and 1 Month
Time frame: 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
Time frame: Measured at 1 month after participant's quit date
Number of Unsuccessful Quit Attempts Lasting > 24 Hrs Reported at One and 6 Months
Time frame: Measured 6 months after participant's quit date
Health Status at 6 Months EuroQol 5D (EQ5D)
Time frame: 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.)
Time frame: Measured 6 months after participant's quit date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10908462Silagy 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.
- BackgroundTobacco 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.
- BackgroundTobacco Advisory Group of the Royal College of Physicians. Nicotine addiction in Britain. London: Royal College of Physicians of London, 2000.
- Background: PubMed 9137956Ashenden 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.
- Background: PubMed 15923472Pierce 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.
- Background: PubMed 11034670Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2000;(4):CD000031. doi: 10.1002/14651858.CD000031.
- Background: PubMed 16820548Tonstad 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.
- Background: PubMed 15755262Ferguson 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.
- Background: PubMed 10796582Stead LF, Lancaster T. Group behaviour therapy programmes for smoking cessation. Cochrane Database Syst Rev. 2000;(2):CD001007. doi: 10.1002/14651858.CD001007.
- BackgroundLancaster T, Stead LF. Individual behavioural counselling for smoking cessation (Cochrane Review). The Cochrane Library, Issue 4, Chichester, UK: John Wiley & Sons, Ltd, 2003.
- Background: PubMed 17506157Coleman 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.
- Background: PubMed 15194717Britton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Coleman, MB ChB principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proactive telephone support, Reactive (standard) telephone support and Offer of voucher for cost-free Nicotine Replacement Therapy in people with Tobacco Smoking, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported, Prolonged Abstinence From Smoking Between a Quit Date and 6 Months Afterwards. (time frame: 6 months from participant's quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00775944, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.