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Implementation of Smoking Cessation Support During Lung Cancer Workup

Primary Purpose

Suspected Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Smoking cessation support
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Suspected Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smoking cessation support

Usual care

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients making an attempt at smoking cessation during lung cancer workup
Binary outcome (Attempt: yes, no)

Secondary Outcome Measures

Motivation to quit smoking
Numeric rating scale (0-10) with higher score indicating stronger motivation
Proportion of patients who are not smoking at the time of measurement
Binary outcome (Currently smoking: yes, no)
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)
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).
Hospitals' number of referrals to municipality-based smoking cessation programmes

Full Information

First Posted
December 17, 2021
Last Updated
April 4, 2023
Sponsor
Vejle Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT05192031
Brief Title
Implementation of Smoking Cessation Support During Lung Cancer Workup
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
295 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smoking cessation support
Arm Type
Experimental
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation support
Intervention Description
Training healthcare professionals to deliver smoking cessation support as part of hospital-based lung cancer workup.
Primary Outcome Measure Information:
Title
Proportion of patients making an attempt at smoking cessation during lung cancer workup
Description
Binary outcome (Attempt: yes, no)
Time Frame
6 weeks after baseline
Secondary Outcome Measure Information:
Title
Motivation to quit smoking
Description
Numeric rating scale (0-10) with higher score indicating stronger motivation
Time Frame
6 weeks, 3, 6, and 12 months after baseline
Title
Proportion of patients who are not smoking at the time of measurement
Description
Binary outcome (Currently smoking: yes, no)
Time Frame
6 weeks, 3, 6, and 12 months after baseline
Title
Quality of life as measured by the 36 item Short Form Survey (SF-36)
Description
SF-36, two components: Mental and Physical. Each components scale has a total score range from 5 (worst health) to 80 (best health)
Time Frame
6 weeks, 3, 6, and 12 months after baseline
Title
Psychosocial consequences of lung cancer workup
Description
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).
Time Frame
6 weeks after baseline
Title
Hospitals' number of referrals to municipality-based smoking cessation programmes
Time Frame
Change from one year before to one year after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Referred to lung cancer workup at participating hospital Able to speak and understand Danish Exclusion Criteria: Unable to complete electronic questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingeborg Farver-Vestergaard, PhD
Phone
+45 79409832
Email
ingeborg.farver@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Løkke, MD
Email
anders.lokke@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Løkke, MD
Organizational Affiliation
Vejle Hospital, Lillebaelt Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ole Hilberg, Prof
Organizational Affiliation
Vejle Hospital, Lillebaelt Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingeborg Farver-Vestergaard
Email
ingeborg.farver@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Implementation of Smoking Cessation Support During Lung Cancer Workup

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