Implementation of Smoking Cessation Support During Lung Cancer Workup

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suspected Lung Cancer
• Intervention / Treatment: Behavioral: Smoking cessation support

• Study Type: Interventional
• Enrollment (Estimated): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark, 7100
    • Vejle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Referred to lung cancer workup at participating hospital
• Able to speak and understand Danish

Exclusion Criteria:

• Unable to complete electronic questionnaires

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital; Bispebjerg Hospital; Aalborg University Hospital; University Hospital, Gentofte, Copenhagen; Naestved Hospital; Hospital of Southern Jutland
• Investigators: Study Director: Anders Løkke, MD, Vejle Hospital, Lillebaelt Hospital; Study Director: Ole Hilberg, Prof, Vejle Hospital, Lillebaelt Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Actual): March 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: STart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No