Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Tobacco Cessation; Tobacco Smoking
• Intervention / Treatment: Behavioral: Intensive Smoking Cessation Intervention

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.

• Study Type: Observational
• Enrollment (Actual): 77380

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With cancer; 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; 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.; Other Names: GSP (Gold Standard Programme for Smoking Cessation)
Without cancer; 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; 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.; Other Names: GSP (Gold Standard Programme for Smoking Cessation)

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Aarhus University Hospital Skejby; Rigshospitalet, Denmark; Danish Cancer Society
• Investigators: Principal Investigator: Mette Rasmussen, PhD, Bispebjerg and Frederiksberg Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2006
• Primary Completion (Actual): January 4, 2018
• Study Completion (Actual): January 4, 2018

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Effectiveness; National database; Gold Standard Programme; Intensive intervention
• Other Study ID Numbers: MS254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No