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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02558101
Protocol/serial number
19480
Study information
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
Acronym
Study hypothesis
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
First Medical Research Ethics Committee, 15/07/2015, ref: 15/LO/1186
Study design
Both; Interventional and Observational; Design type: Process of Care, Screening, Cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measure
Attendance to lung health check measured approximately 2 weeks post receipt of invitation.
Secondary outcome measures
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)
Overall trial start date
01/10/2014
Overall trial end date
31/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 60 to 75 years
2. Recorded as a current smoker from 2010 or later
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned 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 enrolment
1005
Participant 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
Recruitment start date
02/11/2015
Recruitment end date
07/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Medicine
Rayne Building
5 University Street
London
WC1E 6JF
United Kingdom
Funders
Funder type
Government
Funder name
Cancer Research UK (NAEDI)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Intent to publish date: around one year after end of trial.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/27098676
2019 results in https://pubmed.ncbi.nlm.nih.gov/31558626/ (added 27/05/2020)