Study Results
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Basic Information
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COMPLETED
NA
1997 participants
INTERVENTIONAL
2015-11-02
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Control invitation materials
Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types
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:
1. a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes
2. an invitation letter with a pre-scheduled appointment plus the same information booklet
3. a reminder re-invitation letter for those who miss their appointment without cancelling
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.
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.
Interventions
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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:
1. a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes
2. an invitation letter with a pre-scheduled appointment plus the same information booklet
3. a reminder re-invitation letter for those who miss their appointment without cancelling
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
60 Years
75 Years
ALL
Yes
Sponsors
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University College London Hospitals
OTHER
Homerton University Hospital NHS Foundation Trust
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Samuel Janes
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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University College London Hospital NHS Trust
London, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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15/0204
Identifier Type: -
Identifier Source: org_study_id
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