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
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
Scientific
Division of Medicine
5 University Street
London
WC1E 6JF
United Kingdom
Study information
| Study design | Both; Interventional and Observational; Design type: Process of Care, Screening, Cohort study; Randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 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(s) | First Medical Research Ethics Committee, 15/07/2015, ref: 15/LO/1186 |
| 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 |
| 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 study start date | 01/10/2014 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 75 Years |
| Sex | 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 inclusion criteria | 1. Aged 60 to 75 years 2. Recorded as a current smoker from 2010 or later |
| 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
- England
- United Kingdom
Study participating centre
5 University Street
London
WC1E 6JF
United Kingdom
Sponsor information
Hospital/treatment centre
Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
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 date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Intent to publish date: around 1 year after end of trial. |
| 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? |
|---|---|---|---|---|---|
| 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.
