Hull Teaching Hospitals Trust
Hull, HU3 2JZ, United Kingdom
Location status: Recruiting
NCT Number: NCT07171190
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.
Interested in participating?
Request Info55 year–70 year
All sexes
Interventional
Not applicable
Hull, HU3 2JZ, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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):
Exclusion criteria
Inclusion criteria
a): To be eligible for the cluster level randomisation the participant must:
Inclusion criteria
b): To receive the CT Thorax plus ANCCT, the participant must:
Exclusion criteria
Existing LCS exclusion criteria:
Additional TACTICAL1 exclusion criteria:
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.
Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message
Receiving an abdominal CT scan at the same time as the lung scan.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months after invitation
Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months after invitation.
At least 80% of participants offered the ANCCT, accept the invitation and attend the scan
Contact information is provided by the study sponsor or research team.
University of Cambridge
Other
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.
Acronym: TACTICAL1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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