Targeted abdominal CT in conjunction with lung cancer screening – a pilot study (TACTICAL1): a randomised controlled pilot study of adding abdominal non-contrast CT to lung cancer screening CT thorax amongst high lung cancer risk ever-smokers aged 55-70 years
Lung cancer
The TACTICAL1 study participants are high lung cancer risk ever-smokers aged 55-70 years 364 days taking part in the first round of a West Yorkshire and Harrogate Cancer Alliance LCS and a Humber and North Yorkshire Cancer Alliance LCS. The study has two randomisations: (i) Individual randomisation 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). This is to ensure that mentioning the additional scan is not detrimental to LCS uptake. (ii) Cluster randomisation to being offered a CT Thorax only during the LCS assessment (standard of care in LCS; scan control) or offered both CT Thorax and ANCCT during this assessment (scan intervention). This is to pilot this randomisation approach with the near-future aim of a fully powered study. The study includes an embedded process evaluation. There are three major elements to the logistics of TACTICAL1: 1. Adding ANCCT to the LCS process: from invitation to completion of the ANCCT, the existing NHS LCS programmes for the two sites will be leveraged. These LCSs are part of NHS England’s national programme and as such, follow NHS England’s standard protocol. 2. Downstream processes from the scan: reporting of the ANCCT, informing participants of results, dealing with abnormalities and making appropriate referrals into the existing NHS standard pathway of care are new TACTICAL1 specific processes, separate to the LCS, which will be tested and evaluated. 3. Additional non-clinical TACTICAL1 processes: Observations, questionnaires and time-and-motion studies of the end-to-end process together with health care professionals (HCP) and participant invitations to and conducting of qualitative interviews on acceptability of the process are additional non-clinical TACTICAL1 activities undertaken by the TACTICAL1 research team. Participants will receive a phone call and answer some initial screening que
To be randomised at the individual level to receive an invitation letter for LCS (standard of care; invitation control) versus an invitation letter for LCS with potential for an additional abdominal scan (invitation intervention): 1. 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) 2. Be registered with a GP in England 3. Be aged 55-70 years 364 days old at the date of invitation To be eligible for the cluster level randomisation the participant must: 1. Have been individually randomised to the invitation intervention arm 2. Have booked in for an LCS assessment To receive the CT Thorax plus ANCCT, the participant must: 1. Have been randomised to the scan intervention cluster 2. Be invited to attend for an LDCT Thorax based upon scores on either PLCOM2012 or Liverpool Lung Project (LLP) risk prediction models (PLCOM2012 risk of >=1.51% over 6 years or LLPver2 5-year risk of >=2.5%) (17) during the LCS assessment. 3. Have attended the lung scan appointment 4. Have given electronic or written informed consent to participate For the process evaluation: Healthcare professionals: Healthcare professionals involved in the delivery of LCS in any of the study areas who agree to take part. Participants: People individually randomised to the invitation intervention arm who attend the LCS assessment or the scanning unit within the study period and who agree to be interviewed.
For the individual level randomisation to invitation control or invitation intervention: 1. None For the cluster level randomisation to scan intervention or scan control existing LCS exclusion criteria: 1. Participant does not have capacity to give consent (standard criteria for assessing capacity apply) 2. Weight or physical size exceeds restrictions for the scanner (>200 kg) 3. Participant unable to lie flat 4. Poor physical fitness such that treatment with curative intent would be contraindicated 5. Participants who have had a full CT Thorax that meets the image reconstruction parameters of the programme in the last 12 months are not excluded from the lung screening programme, but would have their CT Thorax appointment deferred until 12 months have elapsed since that last scan, provided they still meet all inclusion criteria and have no exclusion criteria – if the deferred appointment is within the timeframe for TACTICAL1, they remain eligible but if deferred appointment is outside the timeframe for TACTICAL1 they would not be eligible. Additional TACTICAL1 exclusion criteria: 1. Had an abdominal CT in the previous 12 months or has one booked within the next 3 months