NCT03750110

Brief Summary

Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening) and by helping people stop smoking. As well as detecting cancers, scans can also show evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will test whether people can be encouraged to quit smoking by giving them pictures from their own scans showing possible lung and heart damage, along with information about how stopping smoking reduces their risk of cancer and heart attacks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,001

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

May 19, 2022

Status Verified

September 1, 2020

Enrollment Period

4.7 years

First QC Date

September 17, 2018

Last Update Submit

May 18, 2022

Conditions

Cancer, LungRespiratory DiseaseHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • 7-day point prevalent CO validated smoking cessation.

    Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation

    Three months after lung screening

Secondary Outcomes (20)

  • Self-reported continuous smoking cessation at three months

    Three months after lung screening

  • Self-reported continuous cessation at 12 months

    12 months after Lung Screening

  • CO validated cessation at 12 months

    12 Months after lung screening

  • Self-reported continuous cessation at 4 weeks

    four weeks after lung screening

  • CO validated cessation at 4 weeks

    four weeks after lung screening

  • +15 more secondary outcomes

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Smoking Cessation NICE PH48 Guidelines

Other: Usual Care

Intervention

ACTIVE COMPARATOR

Smoking Cessation NICE PH48 Guidelines plus personalised feedback from Lung Scan

Other: Intervention

Interventions

InterventionOTHER

In addition to usual care, personalised feedback from the participants screening appointment will be provided; * For participants with emphysema, an image of their own emphysematous lung compared to a library image of normal lung, or a section of their own non-emphysematous lung. Where emphysema is not present, library pictures showing normal and emphysematous lung will be used. * For participants with coronary artery calcification, a cross sectional segment from their chest scan (either horizontal or vertical) showing the calcium compared to a library image of coronary arteries without calcification and/or a healthy section of the participant's own heart scan. Where coronary artery calcification is not present, library pictures showing normal and calcified coronary arteries will be provided.

Intervention
Usual CareOTHER

Smoking cessation support in line with NICE PH48 guidelines

Usual Care

Eligibility Criteria

Age55 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residing in the newly merged Leeds South \& East, Leeds West or Leeds North CCG
  • Registered as a current or ex-smoker in a General Practice participating in YLST
  • Have attended for a 'Lung Health Check' and agreed to see the SCP as part of YLST
  • Smoked within the last month or have exhaled CO reading of 6ppm or above.
  • Have capacity to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Related Publications (3)

  • McInnerney D, Simmonds I, Hancock N, Rogerson S, Lindop J, Gabe R, Vulkan D, Marshall C, Crosbie PAJ, Callister MEJ, Quaife SL. Yorkshire Lung Screening Trial (YLST) pathway navigation study: a protocol for a nested randomised controlled trial to evaluate the effect of a pathway navigation intervention on lung cancer screening uptake. BMJ Open. 2024 Jul 9;14(7):e084577. doi: 10.1136/bmjopen-2024-084577.

    PMID: 38986555DERIVED

  • Murray RL, Brain K, Britton J, Quinn-Scoggins HD, Lewis S, McCutchan GM, Quaife SL, Wu Q, Ashurst A, Baldwin D, Crosbie PAJ, Neal RD, Parrott S, Rogerson S, Thorley R, Callister ME. Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme. BMJ Open. 2020 Sep 10;10(9):e037086. doi: 10.1136/bmjopen-2020-037086.

    PMID: 32912948DERIVED

  • Crosbie PA, Gabe R, Simmonds I, Kennedy M, Rogerson S, Ahmed N, Baldwin DR, Booton R, Cochrane A, Darby M, Franks K, Hinde S, Janes SM, Macleod U, Messenger M, Moller H, Murray RL, Neal RD, Quaife SL, Sculpher M, Tharmanathan P, Torgerson D, Callister ME. Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk. BMJ Open. 2020 Sep 10;10(9):e037075. doi: 10.1136/bmjopen-2020-037075.

    PMID: 32912947DERIVED

MeSH Terms

Conditions

Lung NeoplasmsRespiration DisordersHeart Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Rachael L Murray, BSc MS MSc PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Matthew Callister, MA, BM BCh, MEd, FRCP, PhD

    The Leeds Teaching Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will use a pragmatic, parallel-group, open, randomized controlled trial design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

November 21, 2018

Study Start

July 1, 2017

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

May 19, 2022

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)