AAA - Abdominal Aortic Aneurysm, Kidney Cancers, Renal Cell Carcinoma (Kidney Cancer), Renal Stones
Conditions
Keywords
Screening, NHS Lung Cancer Screening, Kidney cancer, Abdominal cancer, Lung cancer, Abdominal Aortic Aneurysms (AAA), Abdominal screening
Brief summary
Early detection through screening can improve cancer survival by identifying it when it's most treatable. The NHS now offers Lung Cancer Screening (LCS) assessments to people aged 55-74 who have ever smoked. Those at higher risk of lung cancer are offered a lung scan. This group also has a high risk of developing abdominal cancers, such as kidney cancer. A recent study explored whether it would be feasible to extend the lung scan to include the abdomen. Results showed most participants supported this addition, and the number of serious findings was similar to those detected in UK breast or bowel cancer screening programmes. However, the abdominal scan was only offered on the day of the lung scan, giving little time for people to consider their decision. The process also added too much time to be practical for widespread implementation. This new study will: * Test whether mentioning the possible abdominal scan in the initial LCS invitation affects participation in LCS assessments. * Test new processes to assess if the abdominal scan can be added to the lung scan with minimal extra time. * Check if participants can be split between the lung scan only group and lung and abdominal scan group using an approach called 'cluster randomisation'. This will be important in case a bigger trial is needed. * See whether the additional processes are acceptable People aged 55-70 who are invited to the lung cancer screening will be eligible to take part in this study. Only those who are found to be at a high risk of lung cancer after their assessment, and therefore offered a lung scan, will be offered the abdominal scan, provided they have not had an abdominal scan in the previous 12 months or one booked in the next 3 months. This study will take place in two existing lung cancer screening locations in Yorkshire.
Interventions
OTHERLung Cancer Screening Invitation Intervention
Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message
DIAGNOSTIC_TESTAbdominal scan intervention
Receiving an abdominal CT scan at the same time as the lung scan.
Sponsors
Hull University Teaching Hospitals NHS Trust
University of Cambridge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. For the individual level randomisation to invitation control or invitation intervention Inclusion criteria: To be randomised at the individual level to receive an invitation letter for LCS (standard of care; invitation control) versus invitation letter for LCS with potential for an additional abdominal scan (invitation intervention): * Be eligible to be invited to the first round of a West Yorkshire and Harrogate LCS or a Humber and North Yorkshire Cancer Alliance LCS (i.e. have been identified as a smoker or ex-smoker and registered as living within the relevant LCS catchment area). * Be registered with a GP in England. * Be aged 55-70 years 364 days old at the date of invitation.
Exclusion criteria
• None 2. Eligibility criteria for the cluster level randomisation to scan intervention or scan control Inclusion criteria a): To be eligible for the cluster level randomisation the participant must: * Have been individually randomised to the invitation intervention arm * Have booked in for a LCS assessment Inclusion criteria b): To receive the CT Thorax plus ANCCT, the participant must: * Have been randomised to the scan intervention cluster * Be invited to attend for a LDCT Thorax based upon scores on either PLCOM2012 or Liverpool Lung Project (LLP) risk prediction models (PLCOM2012 risk of ≥1.51% over six years or LLPver2 five-year risk of ≥2.5%)14 during the LCS assessment. * Have attended the lung scan appointment * Have given electronic or written informed consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of abdominal scan on throughput | Up to 6 months after invitation | Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT |
| Attendance rate at the LCS phone call | 12 weeks after invitation letter is sent | Attendance rate of the invitation intervention group to the LCS phone call is non-inferior to the attendance rate of the invitation control group and if so, whether it is superior. |
| Cluster randomisation assessment | At the point of LCS assessment, within 12 weeks of invitation | Successful cluster randomisation of participants into scan control and scan intervention groups as demonstrated by groups of similar size. |
| Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience | Up to 6 months after invitation | Over 75% of participants are satisfied or very satisfied with their scanning unit experience as demonstrated by a post-scan feedback questionnaire. |
| Perceived impact of abdominal scan on throughput | Up to 6 months after invitation | Data from daily short questionnaire completed by scanning unit staff shows perceived impact of TACTICAL activities on normal LCS processes is no different when ANCCT is added for at least 80% of days |
| Incremental time taken for each TACTICAL1 task compared with the existing LCS processes. | Up to 6 months after invitation | The observed incremental time taken for each TACTICAL1 task compared with the existing LCS processes for a sub-sample of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants taking up offer of abdominal scan | Up to 6 months after invitation. | At least 80% of participants offered the ANCCT, accept the invitation and attend the scan |
Countries
United Kingdom
Contacts
Primary ContactGrant Stewart
Backup ContactJessica Kitt
Outcome results
None listed