Implementation of Smoking Cessation Support During Lung Cancer Workup

NCT05192031 — Not applicable, Completed, 86 participants, Vejle Hospital

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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

Registry	NCT05192031
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	86 (Actual)
Sponsor	Vejle Hospital (Other); collaborators: Aalborg University Hospital, Aarhus University Hospital, University Hospital, Gentofte, Copenhagen, Naestved Hospital, Odense University Hospital, Zealand University Hospital, Bispebjerg Hospital, Hospital of Southern Jutland
Conditions	Suspected Lung Cancer
Interventions	Smoking cessation support (Behavioral)
Dates	start 2022-03-09, primary completion 2025-03-01, completion 2025-12-31, first posted 2022-01-14, last updated 2026-06-09
Locations	1 site in Denmark

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Smoking cessation support	Experimental	Behavioral: Smoking cessation support
Usual care	No intervention

Smoking cessation support (Behavioral): Training healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup.

+Outcome measures

Primary outcomes

Proportion of patients making an attempt at smoking cessation during lung cancer workup [6 weeks after baseline]: Binary outcome (Attempt: yes, no)

Secondary outcomes

Motivation to quit smoking [6 weeks, 3, 6, and 12 months after baseline]: Numeric rating scale (0-10) with higher score indicating stronger motivation
Proportion of patients who are not smoking at the time of measurement [6 weeks, 3, 6, and 12 months after baseline]: Binary outcome (Currently smoking: yes, no)
Quality of life as measured by the 36 item Short Form Survey (SF-36) [6 weeks, 3, 6, and 12 months after baseline]: SF-36, two components: Mental and Physical. Each components scale has a total score range from 5 (worst health) to 80 (best health)
Psychosocial consequences of lung cancer workup [6 weeks after baseline]: 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).
Hospitals' number of referrals to municipality-based smoking cessation programmes [Change from one year before to one year after intervention]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* Unable to complete electronic questionnaires

+Locations (1)

Facility	City	Country	Status
Vejle Hospital	Vejle	Denmark

+Investigators

Anders Løkke, MD, Study director, Vejle Hospital, Lillebaelt Hospital
Ole Hilberg, Prof, Study director, Vejle Hospital, Lillebaelt Hospital