Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

NCT ID: NCT04198688

Last Updated: 2023-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-03

Study Completion Date

2018-01-04

Brief Summary

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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

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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

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Tobacco Smoking Cancer Tobacco Cessation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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With cancer

Patients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09)

Intensive Smoking Cessation Intervention

Intervention Type 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.

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)

Intensive Smoking Cessation Intervention

Intervention Type 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.

Interventions

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Intensive 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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GSP (Gold Standard Programme for Smoking Cessation)

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mette Rasmussen

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg and Frederiksberg Hospital

References

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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.

Reference Type BACKGROUND
PMID: 37405937 (View on PubMed)

Related Links

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https://www.stopbasen.dk/

The National Danish Smoking Cessation Database (in Danish)

https://doi.org/10.29102/clinhp.19004

A description of the Danish Smoking Cessation Database

Other Identifiers

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MS254

Identifier Type: -

Identifier Source: org_study_id

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