Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

Study Overview
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Brief Summary
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Smoking accounts for approximately 30% of total cancer deaths each year. Even though former studies show that persons with a cancer diagnosis are less likely to smoke than the general population up to 50% of people who smoke and have lung cancer do not stop smoking after their diagnosis or frequently relapse after smoking cessation. Continued smoking leads to increased all-cause mortality, increased cancer-specific mortality, and decreased quality of life. It is well-known that cancer patients are interested in smoking cessation therefore smoking cessation interventions play an important role in the management of people with cancer. This study will evaluate the effectiveness of an intensive smoking cessation interventions on cancer patients in real life. The project provides new knowledge about smokers diagnosed with cancer.

Detailed Description
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This prospective register-based cohort study including smokers attending an intensive smoking cessation intervention (the Gold Standard Programme (GSP)) from 2006-2017 in Denmark. The GSP is a manualised, patient education programme taught by specially trained staff, including pharmacologic strategies.

Official Title
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The Gold Standard Programme (GSP) for Smoking Cessation: Effectiveness in Smokers With and Without Cancer - a Prospective Cohort Study

Conditions
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Tobacco Smoking, Cancer, Tobacco Cessation

Intervention / Treatment
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* Behavioral: Intensive Smoking Cessation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokers registered in the National Danish Smoking Cessation Database between January 2006 until May 2017 Exclusion Criteria: Entries referring to smokers attending more than one smoking cessation intervention (the latest entry will be used) Smokers younger than 18 years of age Smokers attending interventions other than the intensive Gold Standard Programme for smoking cessation (GSP) Smokers where the smoking cessation unit pre-decided not to follow up on their participants Smokers in the non-cancer group diagnosed with benign neoplasms, tumours of unknown etymology or non-melanoma skin cancer (ICD-10 diagnoses: D30.1-9; D32-33; D35.2-4; D41.1-9; D44.3-5; C44, C46.0)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With cancer<br>Patients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09) | Behavioral: Intensive Smoking Cessation Intervention<br>* The intervention comprises 5-6 meetings during six weeks, and can be held in group or as an individual intervention. It is based on counselling and a clearly structured manual-based patient education programme taught by specially trained staff, and contains individual counselling on nicotine replacement therapy or other medical support, according to the level of dependence measured by the Fagerström test score. The first two weeks cover teaching sessions on: ambivalence and motivation, pros and cons of continuous smoking versus cessation, and a quit date is set between the 2. and 3. week. The last 3 sessions cover: risk situations, withdrawal symptoms and medical support for withdrawal symptoms, relapse prevention and how to handle a completely smoke-free life.<br>* Other names: GSP (Gold Standard Programme for Smoking Cessation);|
| Without cancer<br>Patients without cancer (without any of the following ICD-10 diagnoses: C00-99; D09; D30.1-9; D32-33; D35.2-4; D41.1-9; D44.3-5) | Behavioral: Intensive Smoking Cessation Intervention<br>* The intervention comprises 5-6 meetings during six weeks, and can be held in group or as an individual intervention. It is based on counselling and a clearly structured manual-based patient education programme taught by specially trained staff, and contains individual counselling on nicotine replacement therapy or other medical support, according to the level of dependence measured by the Fagerström test score. The first two weeks cover teaching sessions on: ambivalence and motivation, pros and cons of continuous smoking versus cessation, and a quit date is set between the 2. and 3. week. The last 3 sessions cover: risk situations, withdrawal symptoms and medical support for withdrawal symptoms, relapse prevention and how to handle a completely smoke-free life.<br>* Other names: GSP (Gold Standard Programme for Smoking Cessation);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients that are continuously smokefree | Self-reported smoking status, questionnaire completed by telephone interview | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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National database, Effectiveness, Gold Standard Programme, Intensive intervention