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 (NCT)	NCT02558101
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CPMS 19480
Sponsor	University College London Biomedical Research Unit
Funder	Cancer Research UK (NAEDI)

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 of protocol

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

Primary study design	Interventional
Study design	Both; Interventional and Observational; Design type: Process of Care, Screening, Cohort study; Randomized
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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 objectives	The 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
Health condition(s) or problem(s) studied	Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (small cell)
Intervention	Patients 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 type	Other
Primary outcome measure(s)	Attendance to lung health check measured approximately 2 weeks post receipt of invitation
Key secondary outcome measure(s)	1. 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)
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	60 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	2000
Total final enrolment	1005
Key inclusion criteria	1. Aged 60 to 75 years 2. Recorded as a current smoker from 2010 or later
Key exclusion criteria	1. 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
Date of first enrolment	02/11/2015
Date of final enrolment	07/07/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Division of Medicine

Rayne Building
5 University Street
London
WC1E 6JF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The 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?
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
Results article	nodule and cancer outcomes	05/08/2020	10/10/2023	Yes	No
Protocol article	protocol	20/04/2016		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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.