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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Tobacco Smoking

Intervention / Treatment
-----------------
* Behavioral: Proactive telephone support
* Behavioral: Reactive (standard) telephone support
* Drug: Offer of voucher for cost-free Nicotine Replacement Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard support<br>Standard 'Together Programme' telephone support for smoking cessation & advice to obtain nicotine addiction treatment | Behavioral: Reactive (standard) telephone support<br>* 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.<br>* Other names: Together Programme;|
| Active Comparator: Proactive telephone support<br>Proactive support & advice to obtain nicotine addiction treatment | Behavioral: Proactive telephone support<br>* 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.<br>* Other names: Counselling;|
| Active Comparator: Standard support & offer NRT<br>Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Therapy | Behavioral: Reactive (standard) telephone support<br>* 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.<br>* Other names: Together Programme;Drug: Offer of voucher for cost-free Nicotine Replacement Therapy<br>* Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone<br>* Other names: NRT;|
| Active Comparator: Proactive support & offer NRT<br>Proactive telephone support and offer of voucher for cost free NRT | Behavioral: Proactive telephone support<br>* 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.<br>* Other names: Counselling;Drug: Offer of voucher for cost-free Nicotine Replacement Therapy<br>* Offer of voucher for cost-free Nicotine Replacement Therapy over the telephone<br>* Other names: NRT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco, Cigarette, Smoking, Counselling, Nicotine Replacement Therapy, Telephone, Quitline, Helpline