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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,272
- 试验地点
- 2
- 主要终点
- Attendance rate at the LCS phone call
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Attendance rate at the LCS phone call
时间窗: 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
时间窗: 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.
Impact of abdominal scan on throughput
时间窗: Up to 6 months after invitation
Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT
Perceived impact of abdominal scan on throughput
时间窗: 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.
时间窗: 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.
Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience
时间窗: 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.
次要结局
- Percentage of participants taking up offer of abdominal scan(Up to 6 months after invitation.)
研究者
Grant Stewart
Professor Grant Stewart
University of Cambridge