- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02558101
Lung Screen Uptake Trial (Lung-SCREEN)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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England
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London, England, United Kingdom, NW1 2BU
- University College London Hospital NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control invitation materials
Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types
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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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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance to pre-allocated Lung Health Check Appointment
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics of all those invited.
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Smoking data of those attending.
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Data on lung cancer risk of those attending.
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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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.
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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).
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At an expected average of 1 year from the start of the study.
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Past medical and symptom history of those attending.
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Proportion of those invited eligible for screening.
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Uptake of CT scans and willingness to be screening
Time Frame: At an expected average of 1 year from the start of the study.
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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).
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At an expected average of 1 year from the start of the study.
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Psychological burden of screening
Time Frame: At an expected average of 18 months from the start of the study.
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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).
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At an expected average of 18 months from the start of the study.
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Informed decision making
Time Frame: At an expected average of 18 months from the start of the study.
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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).
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At an expected average of 18 months from the start of the study.
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Radiological and clinical outcomes of those screened
Time Frame: At an expected average of 2 years from the start of the study.
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At an expected average of 2 years from the start of the study.
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Numbers of investigations generated from screening
Time Frame: At an expected average of 2 years from the start of the study.
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At an expected average of 2 years from the start of the study.
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Costs generated from screening
Time Frame: At an expected average of 2 years from the start of the study.
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At an expected average of 2 years from the start of the study.
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Adverse events
Time Frame: At an expected average of 2 years from the start of the study.
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At an expected average of 2 years from the start of the study.
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Mortality
Time Frame: At an expected average of 2 years from the start of the study.
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At an expected average of 2 years from the start of the study.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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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At an expected average of 1 year from the start of the study.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel Janes, University College, London
Publications and helpful links
General Publications
- Ruparel M, Quaife SL, Ghimire B, Dickson JL, Bhowmik A, Navani N, Baldwin DR, Duffy S, Waller J, Janes SM. Impact of a Lung Cancer Screening Information Film on Informed Decision-making: A Randomized Trial. Ann Am Thorac Soc. 2019 Jun;16(6):744-751. doi: 10.1513/AnnalsATS.201811-841OC.
- Ruparel M, Quaife SL, Dickson JL, Horst C, Burke S, Taylor M, Ahmed A, Shaw P, Soo MJ, Nair A, Devaraj A, O'Dowd EL, Bhowmik A, Navani N, Sennett K, Duffy SW, Baldwin DR, Sofat R, Patel RS, Hingorani A, Janes SM. Evaluation of cardiovascular risk in a lung cancer screening cohort. Thorax. 2019 Dec;74(12):1140-1146. doi: 10.1136/thoraxjnl-2018-212812. Epub 2019 Sep 26.
- Quaife SL, Ruparel M, Dickson JL, Beeken RJ, McEwen A, Baldwin DR, Bhowmik A, Navani N, Sennett K, Duffy SW, Wardle J, Waller J, Janes SM. Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials. Am J Respir Crit Care Med. 2020 Apr 15;201(8):965-975. doi: 10.1164/rccm.201905-0946OC.
- Kummer S, Waller J, Ruparel M, Cass J, Janes SM, Quaife SL. Mapping the spectrum of psychological and behavioural responses to low-dose CT lung cancer screening offered within a Lung Health Check. Health Expect. 2020 Apr;23(2):433-441. doi: 10.1111/hex.13030. Epub 2020 Jan 21.
- Ruparel M, Quaife SL, Dickson JL, Horst C, Tisi S, Hall H, Taylor MN, Ahmed A, Shaw PJ, Burke S, Soo MJ, Nair A, Devaraj A, Sennett K, Hurst JR, Duffy SW, Navani N, Bhowmik A, Baldwin DR, Janes SM. Prevalence, Symptom Burden, and Underdiagnosis of Chronic Obstructive Pulmonary Disease in a Lung Cancer Screening Cohort. Ann Am Thorac Soc. 2020 Jul;17(7):869-878. doi: 10.1513/AnnalsATS.201911-857OC.
- Quaife SL, Ruparel M, Beeken RJ, McEwen A, Isitt J, Nolan G, Sennett K, Baldwin DR, Duffy SW, Janes SM, Wardle J. The Lung Screen Uptake Trial (LSUT): protocol for a randomised controlled demonstration lung cancer screening pilot testing a targeted invitation strategy for high risk and 'hard-to-reach' patients. BMC Cancer. 2016 Apr 20;16:281. doi: 10.1186/s12885-016-2316-z.
- Ruparel M, Quaife SL, Dickson JL, Horst C, Tisi S, Hall H, Taylor M, Ahmed A, Shaw P, Burke S, Soo MJ, Nair A, Devaraj A, Sennett K, Duffy SW, Navani N, Bhowmik A, Baldwin DR, Janes SM. Lung Screen Uptake Trial: results from a single lung cancer screening round. Thorax. 2020 Oct;75(10):908-912. doi: 10.1136/thoraxjnl-2020-214703. Epub 2020 Aug 5.
- Kummer S, Waller J, Ruparel M, Duffy SW, Janes SM, Quaife SL. Psychological outcomes of low-dose CT lung cancer screening in a multisite demonstration screening pilot: the Lung Screen Uptake Trial (LSUT). Thorax. 2020 Dec;75(12):1065-1073. doi: 10.1136/thoraxjnl-2020-215054. Epub 2020 Oct 21.
- Balata H, Ruparel M, O'Dowd E, Ledson M, Field JK, Duffy SW, Quaife SL, Sharman A, Janes S, Baldwin D, Booton R, Crosbie PAJ. Analysis of the baseline performance of five UK lung cancer screening programmes. Lung Cancer. 2021 Nov;161:136-140. doi: 10.1016/j.lungcan.2021.09.012. Epub 2021 Sep 20.
- Tammemagi MC, Ruparel M, Tremblay A, Myers R, Mayo J, Yee J, Atkar-Khattra S, Yuan R, Cressman S, English J, Bedard E, MacEachern P, Burrowes P, Quaife SL, Marshall H, Yang I, Bowman R, Passmore L, McWilliams A, Brims F, Lim KP, Mo L, Melsom S, Saffar B, Teh M, Sheehan R, Kuok Y, Manser R, Irving L, Steinfort D, McCusker M, Pascoe D, Fogarty P, Stone E, Lam DCL, Ng MY, Vardhanabhuti V, Berg CD, Hung RJ, Janes SM, Fong K, Lam S. USPSTF2013 versus PLCOm2012 lung cancer screening eligibility criteria (International Lung Screening Trial): interim analysis of a prospective cohort study. Lancet Oncol. 2022 Jan;23(1):138-148. doi: 10.1016/S1470-2045(21)00590-8. Epub 2021 Dec 11.
- Hall H, Ruparel M, Quaife SL, Dickson JL, Horst C, Tisi S, Batty J, Woznitza N, Ahmed A, Burke S, Shaw P, Soo MJ, Taylor M, Navani N, Bhowmik A, Baldwin DR, Duffy SW, Devaraj A, Nair A, Janes SM. The role of computer-assisted radiographer reporting in lung cancer screening programmes. Eur Radiol. 2022 Oct;32(10):6891-6899. doi: 10.1007/s00330-022-08824-1. Epub 2022 May 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/0204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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