Suspected Lung CancerNCT05192031
Implementation of Smoking Cessation Support During Lung Cancer Workup
A study testing Smoking cessation support in people with Suspected Lung Cancer, run by Vejle Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suspected Lung Cancer
- What is being tested?
- Smoking cessation support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred to lung cancer workup at participating hospital
- Able to speak and understand Danish
Who cannot join
- Unable to complete electronic questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Smoking cessation support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation supportBehavioural
Training healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup.
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation support | Experimental | Not described Receives: Behavioral: Smoking cessation support |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients making an attempt at smoking cessation during lung cancer workup
Binary outcome (Attempt: yes, no)
Measured: 6 weeks after baseline
Secondary outcomes (5)
Motivation to quit smoking
Numeric rating scale (0-10) with higher score indicating stronger motivation
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 6 weeks after baseline
Hospitals' number of referrals to municipality-based smoking cessation programmes
Measured: Change from one year before to one year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start9 Mar 2022
- Primary completion1 Mar 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or 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
- Responsible party
- Sponsor
- Investigators
- Anders Løkke, MD, Study director, Vejle Hospital, Lillebaelt HospitalOle Hilberg, Prof, Study director, Vejle Hospital, Lillebaelt Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192031
- Sponsor's protocol ID
- START
- Status last verified
- May 2026
- First submitted
- 17 Dec 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05192031
- Acronym / sponsor ID
- START
- Conditions
- Suspected Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or 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
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation support | Experimental | Behavioral: Smoking cessation support |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred to lung cancer workup at participating hospital
- Able to speak and understand Danish
Key exclusion criteria (1 listed)
- Unable to complete electronic questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation supportTraining healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup. | Behavioural | Smoking cessation support |
Primary outcome
Proportion of patients making an attempt at smoking cessation during lung cancer workup
Time frame: 6 weeks after baseline
Binary outcome (Attempt: yes, no)
5 secondary outcomes
Motivation to quit smoking
Time frame: 6 weeks, 3, 6, and 12 months after baseline
Proportion of patients who are not smoking at the time of measurement
Time frame: 6 weeks, 3, 6, and 12 months after baseline
Quality of life as measured by the 36 item Short Form Survey (SF-36)
Time frame: 6 weeks, 3, 6, and 12 months after baseline
Psychosocial consequences of lung cancer workup
Time frame: 6 weeks after baseline
Hospitals' number of referrals to municipality-based smoking cessation programmes
Time frame: Change from one year before to one year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Løkke, MD study director
Vejle Hospital, Lillebaelt Hospital
Ole Hilberg, Prof study director
Vejle Hospital, Lillebaelt Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation support in people with Suspected Lung Cancer, run by Vejle Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients making an attempt at smoking cessation during lung cancer workup (time frame: 6 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.