Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198688
• Other study ID #: MS254
• Status: Completed
• Start date: January 3, 2006
• Est. completion date: January 4, 2018

Study information

• Verified date: July 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77380
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Tobacco Cessation
• Tobacco Smoking

Intervention

Behavioral:
• Intensive Smoking Cessation Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Aarhus University Hospital Skejby, Danish Cancer Society, Rigshospitalet, Denmark

References & Publications (1)

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 5:1-8. doi: 10.1080/0284186X.2023.2228445. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	% of patients that are smokefree	Counsellor observed smoking status, questionnaire completed by counsellor	Last intervention day (6 weeks post baseline)
Other	% of patients that have been smokefree for at least the latest 14 days	Self-reported smoking status, questionnaire completed by telephone interview	6 months
Other	% of patients that are satisfied with the smoking cessation intervention	Self-reported patient-satisfaction, questionnaire completed by telephone interview	6 months
Other	% of patients that are compliant to the treatment	Counsellor observed meeting adherence, questionnaire completed by counsellor	Last intervention day (6 weeks post baseline)
Primary	% of patients that are continuously smokefree	Self-reported smoking status, questionnaire completed by telephone interview	6 months

External Links

•   A description of the Danish Smoking Cessation Database
•   The National Danish Patient Register (in Danish)
•   The National Danish Smoking Cessation Database (in Danish)