Increasing uptake of lung cancer screening in individuals at high risk of lung cancer

ISRCTN ISRCTN21774741
DOI https://doi.org/10.1186/ISRCTN21774741
ClinicalTrials.gov number NCT02558101
Secondary identifying numbers CPMS 19480
Submission date
23/09/2015
Registration date
23/09/2015
Last edited
10/10/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
This study is a randomised controlled trial to test novel invitation methods and materials designed to increase informed uptake of lung cancer screening in individuals at high risk of lung cancer. Lung cancer Low (radiation) Dose Computed Tomography (LDCT) screening has been shown to reduce the number of people who die of lung cancer and of all causes by picking lung cancer up at an earlier stage when treatment is more successful. Screening is now underway in various countries across the world. For the benefits of lung screening to clearly outweigh the harms, screening needs to be targeted at people who are at high risk. However multiple studies have shown that uptake is particularly poor in this group. Qualitative research in this area has highlighted some of the possible explanations for this. This has enabled the development of a novel method of approaching this target population. The aim of this study is is to compare lung screening uptake in people who are sent our new materials designed to improve uptake with people receiving more conventional materials.

Who can participate?
Adults aged 60 to 75 who are current smokers

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a lung health check invitation and those in the second group receive the standard care. Participants are followed up to see if participants attended the health check two weeks after receiving the invitation,.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
October 2014 to December 2019

Who is funding the study?
Cancer Research UK (UK)

Who is the main contact?
Dr Mamta Ruparel

Contact information

Dr Mamta Ruparel
Scientific

Division of Medicine
5 University Street
London
WC1E 6JF
United Kingdom

Study information

Study designBoth; Interventional and Observational; Design type: Process of Care, Screening, Cohort study; Randomized
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleRandomised 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 hypothesisThe aim of this study is to investigate the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment.
Ethics approval(s)First Medical Research Ethics Committee, 15/07/2015, ref: 15/LO/1186
ConditionTopic: Cancer; Subtopic: Lung Cancer; Disease: Lung (small cell)
InterventionPatients are 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.

Control invitation materials: These are similar to standard materials used in other NHS screening programmes.

Targeted invitation materials: The intervention invitation materials are specifically designed and hypothesised to improve uptake to a pre-screening lung health check appointment.

Follow Up Length: 12 month(s)
Intervention typeOther
Primary outcome measureAttendance to lung health check measured approximately 2 weeks post receipt of invitation
Secondary outcome measures1. Adverse eventsare monitored throughout the study in all participants
2. Demographics of attenders and non-attendersis determined at the initial primary care search
3. Eligibility, uptake and willingness for baseline screening scan measured at baseline (lung health check appointment)
4. Informed decision making measured at baseline lung health check appointment, the day after and 3 months after the appointment
5. Investigations and costs generated from screening determined at the end of study
6. Mortality and Survival rates determined at the end of study
7. Psychological burden of screening determined at baseline lung health check appointment, the day after and 3 months after the appointment
8. Radiological and clinical outcomes determined at the end of study
9. Smoking data, lung cancer risk and medical history determined at baseline (lung health check appointment)
Overall study start date01/10/2014
Overall study end date31/12/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit60 Years
Upper age limit75 Years
SexBoth
Target number of participantsPlanned Sample Size: 2000; UK Sample Size: 2000; Description: A total of 2000 patients will be invited for a lung cancer screening appointment, 1000 in each arm. This will provide 90% power to detect a significant difference in uptake of 35% vs. 42%, with 5% significance level and two-sided testing. We estimate 35% uptake in the control group with a 7% increase in uptake in the intervention group based on similar studies examining the effect on screening uptake of ‘psycho-educational’ materials.
Total final enrolment1005
Participant inclusion criteria1. Aged 60 to 75 years
2. Recorded as a current smoker from 2010 or later
Participant exclusion criteria1. Active diagnosis of lung cancer or metastases
2. CT thorax within the past year
3. Inability to consent to study
4. Palliative care register
5. GP's alert to co-morbidity that contraindicates screening or treatment for lung cancer
Recruitment start date02/11/2015
Recruitment end date07/07/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of Medicine
Rayne Building
5 University Street
London
WC1E 6JF
United Kingdom

Sponsor information

University College London Biomedical Research Unit
Hospital/treatment centre

Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6BT
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

Cancer Research UK (NAEDI)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planIntent to publish date: around 1 year after end of trial.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/04/2016 Yes No
Results article cardiovascular risk results 01/12/2019 27/05/2020 Yes No
Results article psychological burden results 01/12/2020 23/10/2020 Yes No
HRA research summary 28/06/2023 No No
Other publications Substudy results 01/06/2019 10/10/2023 Yes No
Other publications Substudy results 01/07/2020 10/10/2023 Yes No
Other publications Substudy results 14/05/2022 10/10/2023 Yes No
Results article nodule and cancer outcomes 05/08/2020 10/10/2023 Yes No

Editorial Notes

10/10/2023: Publication references added.
23/10/2020: Publication reference added.
27/05/2020: Publication reference, total final enrolment number and ClinicalTrials.gov number added.
04/12/2018: The overall trial end date was changed from 21/07/2018 to 31/12/2019.
31/08/2017: Plain English summary has been added. Individual patient level data sharing statement has been added. Publication and dissemination has been added.
18/07/2017: Updated recruitment end date from 31/03/2017 to 07/07/2017. Overall trial end date was updated from 30/06/2018 to 21/07/2018.
09/08/2016: Changed overall study start date from 01/09/2015 to 01/10/2014. Changed overall study end date from 01/09/2016 to 31/06/2018. Changed recruitment start date from 01/09/2015 to. Change recruitment end date from 02/11/2015 to 31/03/2017.
25/04/2016: Publication reference added.