Implementation of Smoking Cessation Support During Lung Cancer Workup

Suspected Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05192031
• Other study ID #: START
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Vejle Hospital
• Contact: Ingeborg Farver-Vestergaard, PhD
• Phone: +45 79409832
• Email: ingeborg.farver[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 295
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to complete electronic questionnaires

Related Conditions & MeSH terms

• Lung Neoplasms
• Suspected Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Denmark	Vejle Hospital	Vejle

Sponsors (9)

Lead Sponsor	Collaborator
Vejle Hospital	Aalborg University Hospital, Aarhus University Hospital, Bispebjerg Hospital, Hospital of Southern Jutland, Naestved Hospital, Odense University Hospital, University Hospital, Gentofte, Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients making an attempt at smoking cessation during lung cancer workup	Binary outcome (Attempt: yes, no)	6 weeks after baseline
Secondary	Motivation to quit smoking	Numeric rating scale (0-10) with higher score indicating stronger motivation	6 weeks, 3, 6, and 12 months after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospitals' number of referrals to municipality-based smoking cessation programmes		Change from one year before to one year after intervention