search
Back to results

Lung Screen Uptake Trial (Lung-SCREEN)

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control invitation materials
Intervention invitation materials
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Screening, Early detection, Health inequality, Uptake

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University College London Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control invitation materials

Intervention invitation materials

Arm Description

Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types

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.

Outcomes

Primary Outcome Measures

Attendance to pre-allocated Lung Health Check Appointment
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).

Secondary Outcome Measures

Demographics of all those invited.
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.
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.
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.
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.
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.
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
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
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
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
Numbers of investigations generated from screening
Costs generated from screening
Adverse events
Mortality

Full Information

First Posted
September 17, 2015
Last Updated
May 22, 2023
Sponsor
University College, London
Collaborators
University College London Hospitals, Homerton University Hospital NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02558101
Brief Title
Lung Screen Uptake Trial
Acronym
Lung-SCREEN
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2015 (Actual)
Primary Completion Date
July 7, 2017 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
University College London Hospitals, Homerton University Hospital NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a "lung health check" and be invited to a baseline screening scan if eligibility criteria are fulfilled.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Screening, Early detection, Health inequality, Uptake

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control invitation materials
Arm Type
Active Comparator
Arm Description
Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types
Arm Title
Intervention invitation materials
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Control invitation materials
Intervention Description
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: a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes an invitation letter with a pre-scheduled appointment plus the same information booklet a reminder re-invitation letter for those who miss their appointment without cancelling
Intervention Type
Behavioral
Intervention Name(s)
Intervention invitation materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance to pre-allocated Lung Health Check Appointment
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Secondary Outcome Measure Information:
Title
Demographics of all those invited.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Smoking data of those attending.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Data on lung cancer risk of those attending.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Past medical and symptom history of those attending.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Proportion of those invited eligible for screening.
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Uptake of CT scans and willingness to be screening
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.
Title
Psychological burden of screening
Description
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).
Time Frame
At an expected average of 18 months from the start of the study.
Title
Informed decision making
Description
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).
Time Frame
At an expected average of 18 months from the start of the study.
Title
Radiological and clinical outcomes of those screened
Time Frame
At an expected average of 2 years from the start of the study.
Title
Numbers of investigations generated from screening
Time Frame
At an expected average of 2 years from the start of the study.
Title
Costs generated from screening
Time Frame
At an expected average of 2 years from the start of the study.
Title
Adverse events
Time Frame
At an expected average of 2 years from the start of the study.
Title
Mortality
Time Frame
At an expected average of 2 years from the start of the study.
Other Pre-specified Outcome Measures:
Title
Tissue bank of biological samples from a high risk cohort
Description
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).
Time Frame
At an expected average of 1 year from the start of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Janes
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London Hospital NHS Trust
City
London
State/Province
England
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31082267
Citation
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.
Results Reference
background
PubMed Identifier
31558626
Citation
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.
Results Reference
background
PubMed Identifier
31825647
Citation
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.
Results Reference
background
PubMed Identifier
31961060
Citation
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.
Results Reference
background
PubMed Identifier
32164439
Citation
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.
Results Reference
background
PubMed Identifier
27098676
Citation
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.
Results Reference
background
PubMed Identifier
32759387
Citation
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.
Results Reference
background
PubMed Identifier
33087548
Citation
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.
Results Reference
background
PubMed Identifier
34583222
Citation
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.
Results Reference
background
PubMed Identifier
34902336
Citation
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.
Results Reference
background
PubMed Identifier
35567604
Citation
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.
Results Reference
background

Learn more about this trial

Lung Screen Uptake Trial

We'll reach out to this number within 24 hrs