Lung Screen Uptake Trial

Study Overview
=================
Brief Summary
-----------------
This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a lung health check and be invited to a baseline screening scan if eligibility criteria are fulfilled.

Detailed Description
-----------------
Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented. In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a lung health check appointment via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds. Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes.

Official Title
-----------------
Randomised Controlled Trial to Test Novel Invitation Methods and Materials Targeted to Increase Informed Uptake of Lung Cancer Screening in Individuals at High Risk of Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: Control invitation materials
* Behavioral: Intervention invitation materials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recorded as a current smoker during the year 2010 or in subsequent years since then. Exclusion Criteria: Active diagnosis of lung cancer or metastases CT thorax within the past year Inability to consent to study Palliative care register GPs alert to co-morbidity that contraindicates screening or treatment for lung cancer

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control invitation materials<br>Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types | Behavioral: Control invitation materials<br>* In the absence of usual care screening invitation materials, the control invitation materials and strategy are based upon the best available materials and methods of existing cancer screening programmes. These are comprised of the following: a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes an invitation letter with a pre-scheduled appointment plus the same information booklet a reminder re-invitation letter for those who miss their appointment without cancelling<br>|
| Experimental: Intervention invitation materials<br>A targeted, stepped and low information burden invitation strategy and materials, specifically designed to improve uptake by reducing barriers to participation among smokers from socioeconomically deprived backgrounds. | Behavioral: Intervention invitation materials<br>* The intervention invitation strategy is comprised of the same stages of invitation materials as the control group. The two differences are i) Instead of the information booklet they will received a targeted leaflet, and ii) the invitation and reminder letters will use indirect phrasing to explain that smokers and ex-smokers are being invited. Together, these manipulations aim to deliver a targeted, stepped and low burden approach to information provision prior to the appointment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance to pre-allocated Lung Health Check Appointment | Invitation to participation in the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics of all those invited. | Demographics of those invited to the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Smoking data of those attending. | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Data on lung cancer risk of those attending. | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening. | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Past medical and symptom history of those attending. | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Proportion of those invited eligible for screening. | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Uptake of CT scans and willingness to be screening | This data will be recorded on enrolment of the participant to the study which will take place from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 1 year from the start of the study. | 
| Psychological burden of screening | This data will be recorded at multiple timepoints following enrolment of the participant to the study. This will therefore occur from from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 18 months from the start of the study. | 
| Informed decision making | This data will be recorded at multiple timepoints following enrolment of the participant to the study. This will therefore occur from from 5 weeks after the start of the study until the end of recruitment (an estimated one year from the start of the study). | At an expected average of 18 months from the start of the study. | 
| Radiological and clinical outcomes of those screened |  | At an expected average of 2 years from the start of the study. | 
| Numbers of investigations generated from screening |  | At an expected average of 2 years from the start of the study. | 
| Costs generated from screening |  | At an expected average of 2 years from the start of the study. | 
| Adverse events |  | At an expected average of 2 years from the start of the study. | 
| Mortality |  | At an expected average of 2 years from the start of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uptake, Screening, Early detection, Health inequality