Tobacco SmokingNCT04198688
Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer
An observational study of Tobacco Smoking and Cancer, run by Bispebjerg Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking, Cancer, Tobacco Cessation
- What is being tested?
- Intensive Smoking Cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 77,380 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2006to 4 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Smokers registered in the National Danish Smoking Cessation Database between January 2006 until May 2017
Who cannot join
- 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)
About this study
Official title: 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.
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.
- Conditions
- Tobacco Smoking, Cancer, Tobacco Cessation
- Being tested
- Intensive Smoking Cessation Intervention
- Keywords
- National database, Effectiveness, Gold Standard Programme, Intensive intervention
- Medical subject headings
- Tobacco Smoking, Neoplasms, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Smoking Cessation InterventionBehavioural
Also called GSP (Gold Standard Programme for Smoking Cessation)
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.
| Study group | Role | What they receive |
|---|---|---|
| With cancer | Patients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09) Receives: 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) Receives: Behavioral: Intensive Smoking Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients that are continuously smokefree
Self-reported smoking status, questionnaire completed by telephone interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start3 Jan 2006
- Primary completion4 Jan 2018
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77,380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital Skejby, Danish Cancer Society
- Responsible party
- Principal investigator, Mette Rasmussen, Bispebjerg Hospital
- Investigators
- Mette Rasmussen, PhD, Principal investigator, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198688
- Sponsor's protocol ID
- MS254
- Status last verified
- Jul 2023
- First submitted
- 6 Dec 2019
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gold Standard Programme (GSP) for Smoking Cessation: Effectiveness in Smokers With and Without Cancer - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04198688
- Acronym / sponsor ID
- MS254
- Conditions
- Tobacco Smoking, Cancer, Tobacco Cessation
- Keywords
- National database, Effectiveness, Gold Standard Programme, Intensive intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77,380 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital Skejby, Danish Cancer Society
- Study start
- 3 Jan 2006 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With cancer | – | Behavioral: Intensive Smoking Cessation InterventionPatients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09) |
| Without cancer | – | Behavioral: Intensive Smoking Cessation InterventionPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Smokers registered in the National Danish Smoking Cessation Database between January 2006 until May 2017
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Smoking Cessation InterventionAlso: GSP (Gold Standard Programme for Smoking Cessation)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. | Behavioural | With cancer, Without cancer |
Primary outcome
% of patients that are continuously smokefree
Time frame: 6 months
Self-reported smoking status, questionnaire completed by telephone interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 37405937Lauridsen 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.
- The National Danish Smoking Cessation Database (in Danish)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Rasmussen, PhD principal investigator
Bispebjerg and Frederiksberg Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Smoking and Cancer, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patients that are continuously smokefree (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.