Implementation of Smoking Cessation Support During Lung Cancer Workup

NCT05192031 | Active Not Recruiting

• 1 other identifier: START
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Suspected Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients making an attempt at smoking cessation during lung cancer workup

  Binary outcome (Attempt: yes, no)

  6 weeks after baseline

Secondary Outcomes (5)

• Motivation to quit smoking

  6 weeks, 3, 6, and 12 months after baseline

• Proportion of patients who are not smoking at the time of measurement

  6 weeks, 3, 6, and 12 months after baseline

• Quality of life as measured by the 36 item Short Form Survey (SF-36)

  6 weeks, 3, 6, and 12 months after baseline

• Psychosocial consequences of lung cancer workup

  6 weeks after baseline

• Hospitals' number of referrals to municipality-based smoking cessation programmes

  Change from one year before to one year after intervention

Study Arms (2)

Smoking cessation support

EXPERIMENTAL

Behavioral: Smoking cessation support

Usual care

NO INTERVENTION

Interventions

Smoking cessation support BEHAVIORAL

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

Smoking cessation support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unable to complete electronic questionnaires

Sponsors & Collaborators

• Vejle Hospital: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• University Hospital, Gentofte, Copenhagen: collaborator
• Naestved Hospital: collaborator
• Odense University Hospital: collaborator
• Zealand University Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Hospital of Southern Jutland: collaborator

Study Sites (1)

Vejle Hospital

Vejle, 7100, Denmark

Location

Study Officials

• Anders Løkke, MD

  Vejle Hospital, Lillebaelt Hospital

  STUDY DIRECTOR

• Ole Hilberg, Prof

  Vejle Hospital, Lillebaelt Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 14, 2022
• Study Start: March 9, 2022
• Primary Completion: March 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)