Smoking cessation by combined medication and counseling in lung cancer patients – effectiveness in a high prevalence real life setting

Study identification

• EU PAS number:
  EUPAS8748
• Study ID:
  30127
• Official title and acronym:
  Smoking cessation by combined medication and counseling in lung cancer patients – effectiveness in a high prevalence real life setting
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Smoking cessation is not only paramount in the prevention but also in the treatment of lung cancer. Indeed, survival in lung cancer is clearly influenced by persistent smoking. Unfortunately little data is available concerning smoking cessation and thus physicians are reluctant to recommend cessation in this setting. Our aim is therefore to evaluate a comprehensive smoking cessation intervention using pharmacotherapy and motivational interviewing in patients with newly diagnosed lung cancer. To understand the obstacles to patients of quitting smoking, depression as well as nicotine withdrawal symptoms will be evaluated. This is a monocenter, 12-week, prospective, observational, non-comparative trial performed at a large University lung cancer center. We assume that 80 patients are willing to participate with 90% being evaluated at 12 weeks. Smoking will be validated biochemically by exhaled carbon monoxide (CO). Nicotine withdrawal symptoms and depression will be evaluated by questionnaires. The primary endpoint is the abstinence rate at week 12 as based on biochemical verification. Secondary endpoints will be safety and 26-week data. The evaluations will be performed according to the intention-to-treat principle. Given previous experience of our group it will be possible to demonstrate the 12-week abstinence rate to be significantly above 45% with a power of at least 80% at a one-sided significance level of 5%. In conclusion this real life study will help to establish the effectiveness of combined medication and counseling in patients with lung cancer.
• Study status:
  Finalised

Research institutions and networks

Institutions

Lungenfachklinik Immenhausen - Universitätsmedizin Göttingen English: Hospital for pulmonary diseases Immenhausen - University of Göttingen

Study timelines

Date when funding contract was signed

Actual:01/12/2014

Study start date

Planned:16/03/2015

Actual:31/03/2015

Data analysis start date

Planned:01/07/2018

Actual:01/11/2018

Date of final study report

Planned:28/02/2019

Actual:06/11/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Pharma GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable