Lung Screen Uptake Trial (Lung-SCREEN)
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ClinicalTrials.gov Identifier: NCT02558101 |
Recruitment Status : Unknown
Verified May 2020 by University College, London.
Recruitment status was: Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : June 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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Lung Cancer | Behavioral: Control invitation materials Behavioral: Intervention invitation materials | Not Applicable |
Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented.
In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a "lung health check appointment" via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds.
Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1997 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Screening |
Official Title: | Randomised Controlled Trial to Test Novel Invitation Methods and Materials Targeted to Increase Informed Uptake of Lung Cancer Screening in Individuals at High Risk of Lung Cancer |
Actual Study Start Date : | November 2, 2015 |
Actual Primary Completion Date : | July 7, 2017 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
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Active Comparator: Control invitation materials
Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types
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Behavioral: Control invitation materials
In the absence of usual care screening invitation materials, the control invitation materials and strategy are based upon the best available materials and methods of existing cancer screening programmes. These are comprised of the following:
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Experimental: Intervention invitation materials
A targeted, stepped and low information burden invitation strategy and materials, specifically designed to improve uptake by reducing barriers to participation among smokers from socioeconomically deprived backgrounds.
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Behavioral: Intervention invitation materials
The intervention invitation strategy is comprised of the same stages of invitation materials as the control group. The two differences are i) Instead of the information booklet they will received a targeted leaflet, and ii) the invitation and reminder letters will use indirect phrasing to explain that smokers and ex-smokers are being invited. Together, these manipulations aim to deliver a targeted, stepped and low burden approach to information provision prior to the appointment. |
- Attendance to pre-allocated Lung Health Check Appointment [ Time Frame: At an expected average of 1 year from the start of the study. ]Invitation to participation in the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study).
- Demographics of all those invited. [ Time Frame: At an expected average of 1 year from the start of the study. ]Demographics of those invited to the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study).
- Smoking data of those attending. [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Data on lung cancer risk of those attending. [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening. [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Past medical and symptom history of those attending. [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Proportion of those invited eligible for screening. [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Uptake of CT scans and willingness to be screening [ Time Frame: At an expected average of 1 year from the start of the study. ]This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Psychological burden of screening [ Time Frame: At an expected average of 18 months from the start of the study. ]This data will be recorded at multiple timepoints following enrolment of the participant to the study. This will therefore occur from from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Informed decision making [ Time Frame: At an expected average of 18 months from the start of the study. ]This data will be recorded at multiple timepoints following enrolment of the participant to the study. This will therefore occur from from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).
- Radiological and clinical outcomes of those screened [ Time Frame: At an expected average of 2 years from the start of the study. ]
- Numbers of investigations generated from screening [ Time Frame: At an expected average of 2 years from the start of the study. ]
- Costs generated from screening [ Time Frame: At an expected average of 2 years from the start of the study. ]
- Adverse events [ Time Frame: At an expected average of 2 years from the start of the study. ]
- Mortality [ Time Frame: At an expected average of 2 years from the start of the study. ]
- Tissue bank of biological samples from a high risk cohort [ Time Frame: At an expected average of 1 year from the start of the study. ]This will be collected at enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study).

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Ages Eligible for Study: | 60 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Recorded as a current smoker during the year 2010 or in subsequent years since then.
Exclusion Criteria:
- Active diagnosis of lung cancer or metastases
- CT thorax within the past year
- Inability to consent to study
- Palliative care register
- GPs alert to co-morbidity that contraindicates screening or treatment for lung cancer

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558101
United Kingdom | |
University College London Hospital NHS Trust | |
London, England, United Kingdom, NW1 2BU |
Principal Investigator: | Samuel Janes | University College, London |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT02558101 |
Other Study ID Numbers: |
15/0204 |
First Posted: | September 23, 2015 Key Record Dates |
Last Update Posted: | June 2, 2020 |
Last Verified: | May 2020 |
Screening Early detection Health inequality Uptake |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |