Implementation of Smoking Cessation Support During Lung Cancer Workup

Study Overview
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Brief Summary
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The aim of the present project is to implement smoking cessation support in hospital-based lung cancer workup. The effect on 1) patients' smoking cessation attempts, motivation, quality of life and psychosocial consequences of lung cancer workup as well as 2) hospitals' number of referrals to municipality-based smoking cessation programmes will be evaluated in a pragmatic, cluster-randomised controlled setup, where participating hospitals will be assigned to the intervention arm (implementation of smoking cessation support) or the control arm (usual practice). Patients' and healthcare professionals' experiences with and barriers towards smoking cessation support will be explored in an interview-based, qualitative study.

Official Title
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Implementation of Smoking Cessation Support During Lung Cancer Workup: a Pragmatic, Cluster-randomised Controlled Trial and an Interview-based Study of Patients' and Healthcare Professionals' Experiences

Conditions
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Suspected Lung Cancer

Intervention / Treatment
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* Behavioral: Smoking cessation support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to lung cancer workup at participating hospital Able to speak and understand Danish Exclusion Criteria: Unable to complete electronic questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation support<br> | Behavioral: Smoking cessation support<br>* Training healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup.<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients making an attempt at smoking cessation during lung cancer workup | Binary outcome (Attempt: yes, no) | 6 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to quit smoking | Numeric rating scale (0-10) with higher score indicating stronger motivation | 6 weeks, 3, 6, and 12 months after baseline | 
| Proportion of patients who are not smoking at the time of measurement | Binary outcome (Currently smoking: yes, no) | 6 weeks, 3, 6, and 12 months after baseline | 
| Quality of life as measured by the 36 item Short Form Survey (SF-36) | SF-36, two components: Mental and Physical. Each components scale has a total score range from 5 (worst health) to 80 (best health) | 6 weeks, 3, 6, and 12 months after baseline | 
| Psychosocial consequences of lung cancer workup | Consequences of Screening - Lung Cancer Questionnaire (adapted to the lung cancer workup setting). Items in Part 1 of the questionnaire focuses on experiences during the cancer workup with a total score range from 0 (low level of psychosocial consequences) to 72 (high level of psychosocial consequences). Items in Part 2 of the questionnaire focuses on experiences after the cancer workup with a total score range from 0 (low level of psychosocial consequences) to 22 (high level of psychosocial consequences). | 6 weeks after baseline | 
| Hospitals' number of referrals to municipality-based smoking cessation programmes |  | Change from one year before to one year after intervention |