<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03750110</url>
  </required_header>
  <id_info>
    <org_study_id>18046</org_study_id>
    <nct_id>NCT03750110</nct_id>
  </id_info>
  <brief_title>Yorkshire Enhanced Stop Smoking Study</brief_title>
  <acronym>YESS</acronym>
  <official_title>The Effect of Adding a Personalised Smoking Cessation Intervention to a Lung Cancer Screening Programme</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yorkshire Cancer Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lung cancer rates are higher in Yorkshire than the rest of the UK, and this is due to higher&#xD;
      rates of smoking. Deaths from lung cancer can be reduced using regular lung scans (screening)&#xD;
      and by helping people stop smoking. As well as detecting cancers, scans can also show&#xD;
      evidence of damage to lungs (emphysema) and heart arteries (calcification). This study will&#xD;
      test whether people can be encouraged to quit smoking by giving them pictures from their own&#xD;
      scans showing possible lung and heart damage, along with information about how stopping&#xD;
      smoking reduces their risk of cancer and heart attacks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lung cancer has the highest mortality of all cancers in the UK and is the single biggest&#xD;
      cause of premature death in Leeds. It disproportionately affects those from lower&#xD;
      socioeconomically deprived communities where rates of smoking are highest. In 2014 in the&#xD;
      Leeds South and East and the Leeds West Clinical Commissioning Group (CCG) areas, lung cancer&#xD;
      standardized incidence rates were 131.4 and 103.3 respectively, compared to an average of&#xD;
      78.3 across England. Lung cancer standardized under-75 mortality rates were 52.4 and 39.3&#xD;
      respectively, compared to 33.26 across England. Poor outcomes from lung cancer treatment are&#xD;
      typically the result of advanced, incurable disease at the time of symptomatic presentation.&#xD;
      In 2011, the US National Lung Screening Trial (NLST) demonstrated a 20% reduction in lung&#xD;
      cancer specific mortality, and a 6.7% reduction in all-cause mortality by annual low-dose CT&#xD;
      (LDCT) screening, and lung cancer screening is now being adopted across North America having&#xD;
      been recommended by the US Preventative Services Task Force (USPSTF) in 2013. A number of&#xD;
      European nations are deliberating introducing screening programmes for lung cancer, and await&#xD;
      the results of the NELSON study, the only European study powered to demonstrate a mortality&#xD;
      reduction, which remains in follow-up. Despite widespread adoption in North America, several&#xD;
      important questions remain regarding the best way to implement lung cancer screening. These&#xD;
      include the optimum selection criteria to identify high-risk individuals to maximise clinical&#xD;
      efficacy and cost-effectiveness, how to increase participation among 'hard to reach'&#xD;
      populations, and how most effectively to embed smoking cessation support into these&#xD;
      programmes. The Yorkshire Lung Screening Trial, funded by Yorkshire Cancer Research ( ISRCTN&#xD;
      reference number 42704678) , seeks to address the first two issues identified above, and is&#xD;
      due to commence screening in 2018. However, there are no currently funded UK studies&#xD;
      specifically investigating optimal smoking cessation provision within a lung cancer screening&#xD;
      programme.&#xD;
&#xD;
      More than 85% of cases of lung cancer are caused by tobacco smoking, and stopping smoking, at&#xD;
      any age, significantly reduces lung cancer risk. It is therefore essential that any lung&#xD;
      cancer screening programme provides smoking cessation support for participants, and doing so&#xD;
      significantly increases the overall success of lung cancer screening programmes. One concern&#xD;
      that has been raised around lung cancer screening for current smokers is the potential 'moral&#xD;
      hazard' arising from a negative (i.e. reassuring) screening result, which may reduce&#xD;
      motivation to quit. Conversely, attendance at a lung cancer screening programme offers a&#xD;
      'teachable moment' for smoking cessation, occurring at a time when participating smokers may&#xD;
      be particularly receptive to offers of help to quit and indeed a negative screen result has&#xD;
      been reported as being perceived as a 'clean slate' as a motivator to stop smoking. This&#xD;
      observation fits with unpublished findings from a screening initiative in Manchester that&#xD;
      despite a high prevalence of emphysema (68%) and coronary artery calcification (74%), most&#xD;
      attendees were fit and relatively asymptomatic (85-90% performance status 0-1 and MRC&#xD;
      dyspnoea scale 1-2), and hence potentially more susceptible to a message that lung damage had&#xD;
      already occurred but clinical impact could be reduced by stopping smoking. One report from&#xD;
      the NELSON study suggested a lower quit rate in screened persons compared to the unscreened&#xD;
      control group, although a statistically significant effect did not persist following&#xD;
      intention to treat analysis. No significant difference was seen between screened and control&#xD;
      populations in the Danish Lung Cancer Screening Study, and the quit rate was significantly&#xD;
      higher in screened versus control populations in the UK Lung Screening (UKLS) Pilot. Evidence&#xD;
      suggests that smoking cessation and LDCT screening have additive effects on survival. An&#xD;
      analysis of participants in the NLST reported a 38% reduction in lung cancer mortality with&#xD;
      the combination of smoking abstinence at 15 years with LDCT screening; in addition, detection&#xD;
      of an abnormality on the CT scan was associated with increased likelihood of smoking&#xD;
      cessation. Further analysis of the NLST showed that arranging the smoking cessation support&#xD;
      at the time of the screening increased quit rates by 46% (although this intervention was&#xD;
      delivered to only 10% of study participants). In addition, research has indicated that adding&#xD;
      smoking cessation interventions to LDCT screening improves the cost effectiveness of such&#xD;
      programmes.&#xD;
&#xD;
      However, while smoking cessation is clearly an effective preventive intervention there is&#xD;
      little evidence on the design and optimization of the smoking cessation interventions and&#xD;
      support used in the screening setting. Evidence from a systematic review published in 2014&#xD;
      showed a benefit of materials tailored to the characteristics of individual smokers, although&#xD;
      the included studies were conducted predominantly in the general population, rather than&#xD;
      screening participants. Less research has been conducted investigating approaches to&#xD;
      cessation in smokers attending for lung cancer screening, although a recent study by Marshall&#xD;
      and colleagues reported that it was feasible to deliver a single tailored session of&#xD;
      motivational interviewing counselling on the day of screening. For historical reasons NHS&#xD;
      Stop Smoking Services (SSS) have evolved across the UK as opt-in facilities, whereby smokers&#xD;
      who decide or agree to try to quit smoking then seek and are delivered help to do so. During&#xD;
      the past five years however, evidence has grown that provision of smoking cessation support&#xD;
      as an opt-out default generates far more quit attempts. We have demonstrated this to be the&#xD;
      case in hospital inpatients, in which the opt-out model approximately doubled service uptake.&#xD;
      Similar findings have been reported in relation to pregnant women setting quit dates in one&#xD;
      NHS Foundation Trust, with uptake more than doubling after 'opt out' referrals were&#xD;
      implemented. A study from the US found that 83% of eligible smokers did not opt out of a&#xD;
      bedside consultation. Pro-active and systematic approaches to smoking cessation provision&#xD;
      were recommended by NICE for pregnant women in 2010 and across all acute, maternity and&#xD;
      mental health settings in 2013.&#xD;
&#xD;
      A recent UK study has also demonstrated the efficacy of including personalised risk&#xD;
      information when inviting participants to smoking cessation services. A randomised controlled&#xD;
      trial compared an individually tailored risk letter with an invitation to attend an&#xD;
      introductory smoking cessation session to a standard generic letter advertising smoking&#xD;
      cessation services. The personalised information was presented as a &quot;Personal Health Risk&#xD;
      Report&quot;, and included information on the participant's general health derived from Quality&#xD;
      and Outcomes Framework (QOF) registered conditions on the GP record. In addition&#xD;
      disease-specific health risks were included in the risk report, with the aim of making the&#xD;
      individual aware of the personal health consequences of continuing to smoke, and their own&#xD;
      individual risk of serious illness. The aim of providing this information was to change the&#xD;
      individual's balance of perceived 'benefits' against their understanding of the harm caused&#xD;
      by smoking. The group receiving personalised risk information had significantly higher&#xD;
      attendance at stop smoking service (17.4% vs. 9.0%, adjusted OR 2.2, 95% CI 1.8- 2.7), higher&#xD;
      completion of a 6-week NHS course (14.5% vs. 7.0%, adjusted OR 2.3, 95% CI 1.8-2.9) and&#xD;
      higher 6- month validated abstinence (9.0% vs. 5.5%, adjusted OR 1.67, 95% CI 1.29-2.14).&#xD;
&#xD;
      To maximize smoking cessation among lung cancer screening participants it is therefore&#xD;
      clearly important that all smokers who attend are provided with cessation support as a&#xD;
      routine opt-out component of the screening visit, and that this support provides cessation&#xD;
      pharmacotherapy and behavioural support in accordance with evidence-based NHS SSS practice.&#xD;
      Furthermore the screening process, including risk assessment for lung cancer and imaging of&#xD;
      the lung parenchyma and coronary arteries, allows an unprecedented opportunity for&#xD;
      personalising the risks and harms of continued smoking, or conversely, the health gains to be&#xD;
      made by successful smoking cessation. However there is currently no evidence on how best to&#xD;
      design services to maximize the opportunity provided by screening participation, and how best&#xD;
      to use the personalised information forthcoming from the screening process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">March 21, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study will use a pragmatic, parallel-group, open, randomized controlled trial design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-day point prevalent CO validated smoking cessation.</measure>
    <time_frame>Three months after lung screening</time_frame>
    <description>Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported continuous smoking cessation at three months</measure>
    <time_frame>Three months after lung screening</time_frame>
    <description>Participant self-report being quit continuously for three months after Lung Screening. Binary question &quot; Have you smoked in the 3 months since Lung Screening, yes or no?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported continuous cessation at 12 months</measure>
    <time_frame>12 months after Lung Screening</time_frame>
    <description>Participant self-reports being quit continuously for 12 months following Lung Screening. Binary question &quot; Have you smoked in the 12 months since Lung Screening, yes or no?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CO validated cessation at 12 months</measure>
    <time_frame>12 Months after lung screening</time_frame>
    <description>Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported continuous cessation at 4 weeks</measure>
    <time_frame>four weeks after lung screening</time_frame>
    <description>Participant self-reports being quit continuously for 4 weeks following Lung Screening. Binary question &quot; Have you smoked in the 4 weeks since Lung Screening, yes or no?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CO validated cessation at 4 weeks</measure>
    <time_frame>four weeks after lung screening</time_frame>
    <description>Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in perceived risk of lung cancer</measure>
    <time_frame>4 weeks after lung screening</time_frame>
    <description>Cancer worry score (UKLS adapted version)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in perceived risk of lung cancer</measure>
    <time_frame>3 months after lung screening</time_frame>
    <description>Cancer worry score (UKLS adapted version)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in perceived risk of lung cancer</measure>
    <time_frame>12 months after lung screening</time_frame>
    <description>Cancer worry score (UKLS adapted version)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in motivation to quit smoking tobacco</measure>
    <time_frame>12 months after lung screening</time_frame>
    <description>Motivation to stop smoking - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in motivation to quit smoking tobacco</measure>
    <time_frame>3 months after lung screening</time_frame>
    <description>Motivation to stop smoking - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in motivation to quit smoking tobacco</measure>
    <time_frame>4 weeks after lung screening</time_frame>
    <description>Motivation to stop smoking - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>12 months after lung screening</time_frame>
    <description>Response efficacy (of stopping smoking) - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>3 months after lung screening</time_frame>
    <description>Response efficacy (of stopping smoking) - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>4 weeks after lung health screening</time_frame>
    <description>Response efficacy (of stopping smoking) - questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>4 weeks after lung screening</time_frame>
    <description>Self efficacy (of stopping smoking) - Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>3 months after lung screening</time_frame>
    <description>Self efficacy (of stopping smoking) - Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence and efficacy beliefs of stopping smoking</measure>
    <time_frame>12 months after lung screening</time_frame>
    <description>Self efficacy (of stopping smoking) - Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -reported changes in health</measure>
    <time_frame>3 months after lung screening</time_frame>
    <description>Health questionnaire (EQ-5D-5L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self -reported changes in health</measure>
    <time_frame>12 months after lung screening</time_frame>
    <description>Health questionnaire (EQ-5D-5L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>7-day point prevalent self reported smoking cessation at 3 months</measure>
    <time_frame>Three months after lung screening</time_frame>
    <description>Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1001</enrollment>
  <condition>Cancer, Lung</condition>
  <condition>Respiratory Disease</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoking Cessation NICE PH48 Guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoking Cessation NICE PH48 Guidelines plus personalised feedback from Lung Scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention</intervention_name>
    <description>In addition to usual care, personalised feedback from the participants screening appointment will be provided;&#xD;
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.&#xD;
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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Smoking cessation support in line with NICE PH48 guidelines</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residing in the newly merged Leeds South &amp; East, Leeds West or Leeds North CCG&#xD;
&#xD;
          -  Registered as a current or ex-smoker in a General Practice participating in YLST&#xD;
&#xD;
          -  Have attended for a 'Lung Health Check' and agreed to see the SCP as part of YLST&#xD;
&#xD;
          -  Smoked within the last month or have exhaled CO reading of 6ppm or above.&#xD;
&#xD;
          -  Have capacity to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachael L Murray, BSc MS MSc PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Callister, MA, BM BCh, MEd, FRCP, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Leeds Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 18, 2022</last_update_submitted>
  <last_update_submitted_qc>May 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750110
org study id: 18046
nct id: NCT03750110
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Lung cancer has the highest mortality of all cancers in the UK and is the single biggest
      cause of premature death in Leeds. It disproportionately affects those from lower
      socioeconomically deprived communities where rates of smoking are highest. In 2014 in the
      Leeds South and East and the Leeds West Clinical Commissioning Group (CCG) areas, lung cancer
      standardized incidence rates were 131.4 and 103.3 respectively, compared to an average of
      78.3 across England. Lung cancer standardized under-75 mortality rates were 52.4 and 39.3
      respectively, compared to 33.26 across England. Poor outcomes from lung cancer treatment are
      typically the result of advanced, incurable disease at the time of symptomatic presentation.
      In 2011, the US National Lung Screening Trial (NLST) demonstrated a 20% reduction in lung
      cancer specific mortality, and a 6.7% reduction in all-cause mortality by annual low-dose CT
      (LDCT) screening, and lung cancer screening is now being adopted across North America having
      been recommended by the US Preventative Services Task Force (USPSTF) in 2013. A number of
      European nations are deliberating introducing screening programmes for lung cancer, and await
      the results of the NELSON study, the only European study powered to demonstrate a mortality
      reduction, which remains in follow-up. Despite widespread adoption in North America, several
      important questions remain regarding the best way to implement lung cancer screening. These
      include the optimum selection criteria to identify high-risk individuals to maximise clinical
      efficacy and cost-effectiveness, how to increase participation among 'hard to reach'
      populations, and how most effectively to embed smoking cessation support into these
      programmes. The Yorkshire Lung Screening Trial, funded by Yorkshire Cancer Research ( ISRCTN
      reference number 42704678) , seeks to address the first two issues identified above, and is
      due to commence screening in 2018. However, there are no currently funded UK studies
      specifically investigating optimal smoking cessation provision within a lung cancer screening
      programme.

      More than 85% of cases of lung cancer are caused by tobacco smoking, and stopping smoking, at
      any age, significantly reduces lung cancer risk. It is therefore essential that any lung
      cancer screening programme provides smoking cessation support for participants, and doing so
      significantly increases the overall success of lung cancer screening programmes. One concern
      that has been raised around lung cancer screening for current smokers is the potential 'moral
      hazard' arising from a negative (i.e. reassuring) screening result, which may reduce
      motivation to quit. Conversely, attendance at a lung cancer screening programme offers a
      'teachable moment' for smoking cessation, occurring at a time when participating smokers may
      be particularly receptive to offers of help to quit and indeed a negative screen result has
      been reported as being perceived as a 'clean slate' as a motivator to stop smoking. This
      observation fits with unpublished findings from a screening initiative in Manchester that
      despite a high prevalence of emphysema (68%) and coronary artery calcification (74%), most
      attendees were fit and relatively asymptomatic (85-90% performance status 0-1 and MRC
      dyspnoea scale 1-2), and hence potentially more susceptible to a message that lung damage had
      already occurred but clinical impact could be reduced by stopping smoking. One report from
      the NELSON study suggested a lower quit rate in screened persons compared to the unscreened
      control group, although a statistically significant effect did not persist following
      intention to treat analysis. No significant difference was seen between screened and control
      populations in the Danish Lung Cancer Screening Study, and the quit rate was significantly
      higher in screened versus control populations in the UK Lung Screening (UKLS) Pilot. Evidence
      suggests that smoking cessation and LDCT screening have additive effects on survival. An
      analysis of participants in the NLST reported a 38% reduction in lung cancer mortality with
      the combination of smoking abstinence at 15 years with LDCT screening; in addition, detection
      of an abnormality on the CT scan was associated with increased likelihood of smoking
      cessation. Further analysis of the NLST showed that arranging the smoking cessation support
      at the time of the screening increased quit rates by 46% (although this intervention was
      delivered to only 10% of study participants). In addition, research has indicated that adding
      smoking cessation interventions to LDCT screening improves the cost effectiveness of such
      programmes.

      However, while smoking cessation is clearly an effective preventive intervention there is
      little evidence on the design and optimization of the smoking cessation interventions and
      support used in the screening setting. Evidence from a systematic review published in 2014
      showed a benefit of materials tailored to the characteristics of individual smokers, although
      the included studies were conducted predominantly in the general population, rather than
      screening participants. Less research has been conducted investigating approaches to
      cessation in smokers attending for lung cancer screening, although a recent study by Marshall
      and colleagues reported that it was feasible to deliver a single tailored session of
      motivational interviewing counselling on the day of screening. For historical reasons NHS
      Stop Smoking Services (SSS) have evolved across the UK as opt-in facilities, whereby smokers
      who decide or agree to try to quit smoking then seek and are delivered help to do so. During
      the past five years however, evidence has grown that provision of smoking cessation support
      as an opt-out default generates far more quit attempts. We have demonstrated this to be the
      case in hospital inpatients, in which the opt-out model approximately doubled service uptake.
      Similar findings have been reported in relation to pregnant women setting quit dates in one
      NHS Foundation Trust, with uptake more than doubling after 'opt out' referrals were
      implemented. A study from the US found that 83% of eligible smokers did not opt out of a
      bedside consultation. Pro-active and systematic approaches to smoking cessation provision
      were recommended by NICE for pregnant women in 2010 and across all acute, maternity and
      mental health settings in 2013.

      A recent UK study has also demonstrated the efficacy of including personalised risk
      information when inviting participants to smoking cessation services. A randomised controlled
      trial compared an individually tailored risk letter with an invitation to attend an
      introductory smoking cessation session to a standard generic letter advertising smoking
      cessation services. The personalised information was presented as a "Personal Health Risk
      Report", and included information on the participant's general health derived from Quality
      and Outcomes Framework (QOF) registered conditions on the GP record. In addition
      disease-specific health risks were included in the risk report, with the aim of making the
      individual aware of the personal health consequences of continuing to smoke, and their own
      individual risk of serious illness. The aim of providing this information was to change the
      individual's balance of perceived 'benefits' against their understanding of the harm caused
      by smoking. The group receiving personalised risk information had significantly higher
      attendance at stop smoking service (17.4% vs. 9.0%, adjusted OR 2.2, 95% CI 1.8- 2.7), higher
      completion of a 6-week NHS course (14.5% vs. 7.0%, adjusted OR 2.3, 95% CI 1.8-2.9) and
      higher 6- month validated abstinence (9.0% vs. 5.5%, adjusted OR 1.67, 95% CI 1.29-2.14).

      To maximize smoking cessation among lung cancer screening participants it is therefore
      clearly important that all smokers who attend are provided with cessation support as a
      routine opt-out component of the screening visit, and that this support provides cessation
      pharmacotherapy and behavioural support in accordance with evidence-based NHS SSS practice.
      Furthermore the screening process, including risk assessment for lung cancer and imaging of
      the lung parenchyma and coronary arteries, allows an unprecedented opportunity for
      personalising the risks and harms of continued smoking, or conversely, the health gains to be
      made by successful smoking cessation. However there is currently no evidence on how best to
      design services to maximize the opportunity provided by screening participation, and how best
      to use the personalised information forthcoming from the screening process.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will use a pragmatic, parallel-group, open, randomized controlled trial design
primary purpose: Treatment
masking: None (Open Label)
measure: 7-day point prevalent CO validated smoking cessation.
time frame: Three months after lung screening
description: Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation
measure: Self-reported continuous smoking cessation at three months
time frame: Three months after lung screening
description: Participant self-report being quit continuously for three months after Lung Screening. Binary question " Have you smoked in the 3 months since Lung Screening, yes or no?"
measure: Self-reported continuous cessation at 12 months
time frame: 12 months after Lung Screening
description: Participant self-reports being quit continuously for 12 months following Lung Screening. Binary question " Have you smoked in the 12 months since Lung Screening, yes or no?"
measure: CO validated cessation at 12 months
time frame: 12 Months after lung screening
description: Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation
measure: Self-reported continuous cessation at 4 weeks
time frame: four weeks after lung screening
description: Participant self-reports being quit continuously for 4 weeks following Lung Screening. Binary question " Have you smoked in the 4 weeks since Lung Screening, yes or no?"
measure: CO validated cessation at 4 weeks
time frame: four weeks after lung screening
description: Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation
measure: Changes in perceived risk of lung cancer
time frame: 4 weeks after lung screening
description: Cancer worry score (UKLS adapted version)
measure: Changes in perceived risk of lung cancer
time frame: 3 months after lung screening
description: Cancer worry score (UKLS adapted version)
measure: Changes in perceived risk of lung cancer
time frame: 12 months after lung screening
description: Cancer worry score (UKLS adapted version)
measure: Changes in motivation to quit smoking tobacco
time frame: 12 months after lung screening
description: Motivation to stop smoking - questionnaire
measure: Changes in motivation to quit smoking tobacco
time frame: 3 months after lung screening
description: Motivation to stop smoking - questionnaire
measure: Changes in motivation to quit smoking tobacco
time frame: 4 weeks after lung screening
description: Motivation to stop smoking - questionnaire
measure: Changes in confidence and efficacy beliefs of stopping smoking
time frame: 12 months after lung screening
description: Response efficacy (of stopping smoking) - questionnaire
measure: Changes in confidence and efficacy beliefs of stopping smoking
time frame: 3 months after lung screening
description: Response efficacy (of stopping smoking) - questionnaire
measure: Changes in confidence and efficacy beliefs of stopping smoking
time frame: 4 weeks after lung health screening
description: Response efficacy (of stopping smoking) - questionnaire
measure: Confidence and efficacy beliefs of stopping smoking
time frame: 4 weeks after lung screening
description: Self efficacy (of stopping smoking) - Questionnaire
measure: Confidence and efficacy beliefs of stopping smoking
time frame: 3 months after lung screening
description: Self efficacy (of stopping smoking) - Questionnaire
measure: Confidence and efficacy beliefs of stopping smoking
time frame: 12 months after lung screening
description: Self efficacy (of stopping smoking) - Questionnaire
measure: Self -reported changes in health
time frame: 3 months after lung screening
description: Health questionnaire (EQ-5D-5L)
measure: Self -reported changes in health
time frame: 12 months after lung screening
description: Health questionnaire (EQ-5D-5L)
measure: 7-day point prevalent self reported smoking cessation at 3 months
time frame: Three months after lung screening
description: Exhaled Carbon Monoxide reading of 6ppm or less to validate smoking cessation
arm group label: Usual Care
arm group type: Active Comparator
description: Smoking Cessation NICE PH48 Guidelines
arm group label: Intervention
arm group type: Active Comparator
description: Smoking Cessation NICE PH48 Guidelines plus personalised feedback from Lung Scan
intervention type: Other
intervention name: Intervention
description: 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.
arm group label: Intervention
intervention type: Other
intervention name: Usual Care
description: Smoking cessation support in line with NICE PH48 guidelines
arm group label: Usual Care
criteria: 
gender: Male
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rachael L Murray, BSc MS MSc PhD
role: Principal Investigator
affiliation: University of Nottingham
last name: Matthew Callister, MA, BM BCh, MEd, FRCP, PhD
role: Principal Investigator
affiliation: The Leeds Teaching Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Heart Diseases
sharing ipd: No