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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04198688
Enrollment
77380
Registered
2019-12-13
Start date
2006-01-03
Completion date
2018-01-04
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Tobacco Cessation, Tobacco Smoking

Keywords

National database, Effectiveness, Gold Standard Programme, Intensive intervention

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.

Interventions

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.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Aarhus University Hospital Skejby
CollaboratorOTHER
Danish Cancer Society
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
% of patients that are continuously smokefree6 monthsSelf-reported smoking status, questionnaire completed by telephone interview

Other

MeasureTime frameDescription
% of patients that are smokefreeLast intervention day (6 weeks post baseline)Counsellor observed smoking status, questionnaire completed by counsellor
% of patients that have been smokefree for at least the latest 14 days6 monthsSelf-reported smoking status, questionnaire completed by telephone interview
% of patients that are satisfied with the smoking cessation intervention6 monthsSelf-reported patient-satisfaction, questionnaire completed by telephone interview
% of patients that are compliant to the treatmentLast intervention day (6 weeks post baseline)Counsellor observed meeting adherence, questionnaire completed by counsellor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026