Lung cancer Cancer Cancer/ Malignant neoplasms of respiratory and intrathoracic organs
Conditions
Interventions
Current interventions as of 20/02/2024:
The trialists wish to use a Zelen’s design, where they randomise 55-80 year old smokers or ex-smokers to intervention or usual care groups before they approac
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria for entry into the randomisation cohort are: 1. Registered with a participating General Practice within the Leeds CCG area 2. Registered as current or ex-smoker in primary care databases 3. Age between 55 and 80 years (inclusive) at the time of randomisation The inclusion criteria for being invited to attend a mobile lung health check following contacting the telephone triage service are any of: 1. 30 pack year history of smoking and current smoker, and quit within the last 15 years, (USPSTF criteria) 2. Lung cancer risk of =1.51% over 6 years as calculated by the PLCOM2012 score 3. Lung cancer risk of =5% over 5 years as calculated by the LLPv2. score
Exclusion criteria
Exclusion criteria: 1. Unable to provide written informed consent 2. Diagnosed with lung cancer within past 5 years 3. Diagnosed with incurable cancer 4. CT thorax within past 12 months 5. Registered on any of the following primary care databases: 5.1. Palliative care register 5.2. Dementia register 5.3. Frailty index > (to be decided) 6. Recorded type 2 objection to participation in the General Practice Extraction Service
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 20/02/2024: YLST Primary Outcome Measures 1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria 2. Lung cancers identified in participants selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening 3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study Pathway Navigator Primary Outcomes 1. The number undergoing initial telephone assessment of lung cancer risk. 2. The number undergoing a LDCT screening scan. _____ Previous primary outcome measures as of 02/04/2020: 1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria 2. Lung cancers identified in participants selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening 3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study _____ Previous primary outcome measures: 1. The proportion of the study population allocated to intervention who undergo telephone assessment and are screened according to the USPSTF, PLCO and LLP criteria, measured at initial telephone triage at study baseline 2. Lung cancers identified in patients selected for LDCT screening according to the USPSTF, PLCO and LLP criteria over two rounds of biennial screening, measured at study end (5-6 years following initial recruitment) 3. The incidence of advanced lung cancer in the intervention and control arms over the course of the study, measured using local medical records and national database (National Cancer Registration and Analysis Service) at study end (5-6 years following initial recruitment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/02/2024: YLST Secondary Outcome Measures 1. Incremental cost-effectiveness ratio for community-based lung cancer screening overall and according to the three criteria for identifying candidates for screening 2. Screening performance including the following parameters: 2.1. Cancer detection rate and number needed to screen to detect one lung cancer according to risk criteria over two screening rounds 2.2. False-positive and false-negative rate 2.3. Rate of investigation of benign disease and benign surgical resection rate 2.4. Attendance by LDCT screening round and according to participant characteristics (age, sex, smoking status, ethnicity and SES) 2.5. Treatment of screen-detected lung cancer including surgical resection rate 2.6. Investigations, treatments and adverse events generated from screening including incidental findings 2.7. Interval cancers and recall rates in those undergoing screening 3. Smoking prevalence at the start and end of the study in the intervention arm and usual care arm 4. Participation rates in telephone assessment by age, sex, smoking status, ethnicity and SES 5. Route to diagnosis, histological subtype, stage and treatment of lung cancers in the intervention (LDCT screened group, eligible respondents, non-respondents and ineligible low risk responders) and usual care arms 6. Lung cancer and all-cause mortality by trial arm 7. Numbers of nodules detected, proportion with eventual diagnosis of cancer by: size (volume), Pancan malignancy risk prediction score and volumetry-derived Volume Doubling Time (VDT) 8. Prevalence of undiagnosed airflow obstruction and coronary artery calcification in the screened population 9. Quality of life measured using EQ-5D and SF-12 scores Pathway Navigator Secondary Outcomes Secondary outcomes include: demographic, clinical and risk parameters of people undergoing telephone risk-assessment; number of people eligible for screening following telephone risk-assess | — |
Countries
England, United Kingdom
Outcome results
None listed