Lung Screen Uptake Trial

NCT02558101 | Completed DMC

• 1 other identifier: 15/0204
• Study Type: interventional
• Target: 1,997
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Screening; Early detection; Health inequality; Uptake

Outcome Measures

Primary Outcomes (1)

• 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).

  At an expected average of 1 year from the start of the study.

Secondary Outcomes (14)

• Demographics of all those invited.

  At an expected average of 1 year from the start of the study.

• Smoking data of those attending.

  At an expected average of 1 year from the start of the study.

• Data on lung cancer risk of those attending.

  At an expected average of 1 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.

  At an expected average of 1 year from the start of the study.

• Past medical and symptom history of those attending.

  At an expected average of 1 year from the start of the study.

Other Outcomes (1)

• Tissue bank of biological samples from a high risk cohort

  At an expected average of 1 year from the start of the study.

Study Arms (2)

Control invitation materials

ACTIVE COMPARATOR

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

Behavioral: Control invitation materials

Intervention invitation materials

EXPERIMENTAL

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.

Behavioral: Intervention invitation materials

Interventions

Control invitation materials BEHAVIORAL

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

Control invitation materials

Intervention invitation materials BEHAVIORAL

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.

Intervention invitation materials

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recorded as a current smoker during the year 2010 or in subsequent years since then.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator
• Homerton University Hospital NHS Foundation Trust: collaborator

Study Sites (1)

University College London Hospital NHS Trust

London, England, NW1 2BU, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 31082267 BACKGROUND

• 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.

  PMID: 31558626 BACKGROUND

• 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.

  PMID: 31825647 BACKGROUND

• 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.

  PMID: 31961060 BACKGROUND

• 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.

  PMID: 32164439 BACKGROUND

• 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.

  PMID: 27098676 BACKGROUND

• 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.

  PMID: 32759387 BACKGROUND

• 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.

  PMID: 33087548 BACKGROUND

• 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.

  PMID: 34583222 BACKGROUND

• 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.

  PMID: 34902336 BACKGROUND

• 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.

  PMID: 35567604 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Samuel Janes

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 23, 2015
• Study Start: November 2, 2015
• Primary Completion: July 7, 2017
• Study Completion: December 31, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

GB (1)