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| Name | Class |
|---|---|
| Hull University Teaching Hospitals NHS Trust | OTHER_GOV |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invitation control arm | Active Comparator | Invited to NHS Lung Cancer Screening to assess lung cancer risk via letter or text message, following the normal process |
|
| Invitation intervention arm | Experimental | Will have additional text included in the standard Lung Cancer Screening letter or text explaining that, if eligible, they may also be offered a scan of their abdomen at the same time as their lungs. |
|
| Scan control arm | Active Comparator | For the scan control batches, those who are 'high risk' following the LCS assessment will have an appointment booked for LCS in the normal way by the LCS assessor. |
|
| Scan intervention arm | Experimental | Those who are 'high risk' following the LCS assessment will be invited to have an abdominal CT scan at the same time as their lung scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Cancer Screening Invitation Intervention | Other | Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance rate at the LCS phone call | 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. | 12 weeks after invitation letter is sent |
| Cluster randomisation assessment | Successful cluster randomisation of participants into scan control and scan intervention groups as demonstrated by groups of similar size. | At the point of LCS assessment, within 12 weeks of invitation |
| Impact of abdominal scan on throughput | Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT | Up to 6 months after invitation |
| Perceived impact of abdominal scan on throughput | 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 | Up to 6 months after invitation |
| Incremental time taken for each TACTICAL1 task compared with the existing LCS processes. | The observed incremental time taken for each TACTICAL1 task compared with the existing LCS processes for a sub-sample of participants. | Up to 6 months after invitation |
| Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience | Over 75% of participants are satisfied or very satisfied with their scanning unit experience as demonstrated by a post-scan feedback questionnaire. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants taking up offer of abdominal scan | At least 80% of participants offered the ANCCT, accept the invitation and attend the scan | Up to 6 months after invitation. |
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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):
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:
Inclusion criteria b): To receive the CT Thorax plus ANCCT, the participant must:
Exclusion criteria
Existing LCS exclusion criteria:
Additional TACTICAL1 exclusion criteria:
• Had an abdominal CT in the previous 12 months or has one booked within the next 3 months.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant Stewart | Contact | 01223 331199 | gds35@cam.ac.uk | |
| Jessica Kitt | Contact | jk896@cam.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Teaching Hospitals Trust | Recruiting | Hull | HU3 2JZ | United Kingdom |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D017544 | Aortic Aneurysm, Abdominal |
| D053040 | Nephrolithiasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Abdominal scan intervention | Diagnostic Test | Receiving an abdominal CT scan at the same time as the lung scan. |
|
| Up to 6 months after invitation |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D052878 | Urolithiasis |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |