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Completed

NCT Number: NCT04198688

Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

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.

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Key information

Conditions

Tobacco Smoking Behavior Cancer Health Behavior Neoplasms Smoking Tobacco Cessation Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: GSP (Gold Standard Programme for Smoking Cessation)

Primary outcomes

  1. % of patients that are continuously smokefree

    Time frame: 6 months

    Self-reported smoking status, questionnaire completed by telephone interview

Other outcomes

  1. % of patients that are smokefree

    Time frame: Last intervention day (6 weeks post baseline)

    Counsellor observed smoking status, questionnaire completed by counsellor

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

    Time frame: 6 months

    Self-reported smoking status, questionnaire completed by telephone interview

  3. % of patients that are satisfied with the smoking cessation intervention

    Time frame: 6 months

    Self-reported patient-satisfaction, questionnaire completed by telephone interview

  4. % of patients that are compliant to the treatment

    Time frame: Last intervention day (6 weeks post baseline)

    Counsellor observed meeting adherence, questionnaire completed by counsellor

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Aarhus University Hospital Skejby
  • Danish Cancer Society
  • Rigshospitalet, Denmark

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2019
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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