Targeted Abdominal CT in Conjunction With Lung Cancer Screening

Official title

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.

Overview

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

• Other Lung Cancer Screening Invitation Intervention
  Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message
• Diagnostic test Abdominal scan intervention
  Receiving an abdominal CT scan at the same time as the lung scan.

Primary outcome measures

• Attendance rate at the LCS phone call [Time frame: 12 weeks after invitation letter is sent]
• Cluster randomisation assessment [Time frame: At the point of LCS assessment, within 12 weeks of invitation]
• Impact of abdominal scan on throughput [Time frame: Up to 6 months after invitation]
• Perceived impact of abdominal scan on throughput [Time frame: Up to 6 months after invitation]
• Incremental time taken for each TACTICAL1 task compared with the existing LCS processes. [Time frame: Up to 6 months after invitation]
• Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience [Time frame: Up to 6 months after invitation]

Secondary outcome measures (1)

• Percentage of participants taking up offer of abdominal scan [Time frame: Up to 6 months after invitation.]

Eligibility criteria

• 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
• 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

Exclusion criteria

Existing LCS exclusion criteria:

• Participant does not have capacity to give consent (standard criteria for assessing capacity apply).
• Weight or physical size exceeds restrictions for scanner (>200kg).
• Participant unable to lie flat.
• Poor physical fitness such that treatment with curative intent would be contra-indicated.
• 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:

• Had an abdominal CT in the previous 12 months or has one booked within the next 3 months.
• For HNY, this is checked before the LCS assessment. Therefore, participants will be excluded before the LCS assessment.
• For WYH, this is only checked after the LCS assessment. Therefore, anyone having had an abdominal CT in the previous 12 months or with one booked within the next 3 months will be excluded at this point (see 8.6).
• Eligibility criteria for the process evaluation Health care 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Screening

Study locations

United Kingdom · 1 center

• Hull Teaching Hospitals Trust — Hull

Identifiers

NCT: NCT07171190 · G128732

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗