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CompletedNCT04198688Updated Jul 10, 2023

Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

An observational study in Tobacco Smoking, Cancer and Tobacco Cessation, sponsored by Bispebjerg Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Bispebjerg Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
77,380
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tobacco Smoking
  • Cancer
  • Tobacco Cessation

Keywords

  • National database
  • Effectiveness
  • Gold Standard Programme
  • Intensive intervention
03

In context

Tobacco Smoking

81 studies on the registry are indexed under Tobacco Smoking; 27 are open to participants now.

This study's enrollment of 77,380 is above the median of 151 across 11 observational studies indexed under Tobacco Smoking.

Browse Tobacco Smoking studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
77,380 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralIntensive 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.

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

06

What researchers measure

Primary outcomes

  1. % of patients that are continuously smokefree

    Self-reported smoking status, questionnaire completed by telephone interview

    Time frame: 6 months

Other outcomes

  1. % of patients that are smokefree

    Counsellor observed smoking status, questionnaire completed by counsellor

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

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

    Self-reported smoking status, questionnaire completed by telephone interview

    Time frame: 6 months

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

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

    Time frame: 6 months

  4. % of patients that are compliant to the treatment

    Counsellor observed meeting adherence, questionnaire completed by counsellor

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

07

Study locations

No study locations are listed for this record.

08

References and documents

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;62(7):774-781. doi: 10.1080/0284186X.2023.2228445. Epub 2023 Jul 5. PubMed 37405937 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2006 to primary completion in Jan 2018, 144 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2019
First posted
Dec 13, 2019
StartActual
Jan 3, 2006
Primary completionActual
Jan 4, 2018
CompletionActual
Jan 4, 2018
Last update
Jul 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04198688
Collaborators
Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital Skejby, Danish Cancer Society
Responsible party
Mette Rasmussen (Senior Researcher, Bispebjerg Hospital) — Principal investigator
First posted
Dec 13, 2019
Start date
Jan 3, 2006
Primary completion
Jan 4, 2018
Completion
Jan 4, 2018
Last update
Jul 10, 2023

Study contacts

Mette Rasmussen, PhD
principal investigator · Bispebjerg and Frederiksberg Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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