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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05192031

Enrollment

Registered

2022-01-14

Start date

2022-03-09

Completion date

2025-12-31

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected Lung Cancer

Brief 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.

Interventions

BEHAVIORALSmoking cessation support

Training healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Unable to complete electronic questionnaires

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Countries

Denmark

Contacts

STUDY_DIRECTORAnders Løkke, MD

Vejle Hospital, Lillebaelt Hospital

STUDY_DIRECTOROle Hilberg, Prof