Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

NCT04198688 | Completed

• 1 other identifier: MS254
• Study Type: observational
• Target: 77,380
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Smoking; Cancer; Tobacco Cessation

Keywords

National database; Effectiveness; Gold Standard Programme; Intensive intervention

Outcome Measures

Primary Outcomes (1)

• % of patients that are continuously smokefree

  Self-reported smoking status, questionnaire completed by telephone interview

  6 months

Other Outcomes (4)

• % of patients that are smokefree

  Last intervention day (6 weeks post baseline)

• % of patients that have been smokefree for at least the latest 14 days

  6 months

• % of patients that are satisfied with the smoking cessation intervention

  6 months

Study Arms (2)

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

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

Interventions

Intensive Smoking Cessation Intervention BEHAVIORAL

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.

Also known as: GSP (Gold Standard Programme for Smoking Cessation)

With cancer; Without cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Smokers registered in the National Danish Smoking Cessation Database between January 2006 until May 2017

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Aarhus University Hospital Skejby: collaborator
• Danish Cancer Society: collaborator

Related 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;62(7):774-781. doi: 10.1080/0284186X.2023.2228445. Epub 2023 Jul 5.

  PMID: 37405937 BACKGROUND

Related Links

• The National Danish Smoking Cessation Database (in Danish)

MeSH Terms

Conditions

Tobacco Smoking; Neoplasms; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Study Officials

• Mette Rasmussen, PhD

  Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 13, 2019
• Study Start: January 3, 2006
• Primary Completion: January 4, 2018
• Study Completion: January 4, 2018
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share