Clinical trial NCT04198688: Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer
Official title: The Gold Standard Programme (GSP) for Smoking Cessation: Effectiveness in Smokers With and Without Cancer - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Smoking
Cancer
Tobacco Cessation
Keywords: National database
Effectiveness
Gold Standard Programme
Intensive intervention
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Aarhus University Hospital Skejby
name: Danish Cancer Society
First posted: 2019-12-13
Enrollment: 77380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population in this study are smokers in Denmark, with or without cancer, who are motivated to attempt to quit smoking, and have attented an intensive smoking cessation programme.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: % of patients that are continuously smokefree
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: % of patients that are smokefree
timeFrame: Last intervention day (6 weeks post baseline)
measure: % of patients that have been smokefree for at least the latest 14 days
timeFrame: 6 months
measure: % of patients that are satisfied with the smoking cessation intervention
timeFrame: 6 months
measure: % of patients that are compliant to the treatment
timeFrame: Last intervention day (6 weeks post baseline)
Locations:
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital
name: Mette Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauridsen SV, Jensen BT, Tonnesen H, Dalton SO, Rasmussen M. The gold standard program (GSP) for smoking cessation: a cohort study of its effectiveness among smokers with and without cancer. Acta Oncol. 2023 Jul;62(7):774-781. doi: 10.1080/0284186X.2023.2228445. Epub 2023 Jul 5.