Lung Screen Uptake Trial

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Control invitation materials; Behavioral: Intervention invitation materials

• Registration Number: NCT02558101
• Lead Sponsor: University College, London

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.

Study Timeline

• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2015-11-02
• Primary Completion: 2017-07-07
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1997

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control invitation materials	Control invitation materials	Invitation materials and strategy mimicking those of existing UK screening programmes for other cancer types
Intervention invitation materials	Intervention invitation materials	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.

Primary Outcome Measures

Name	Time	Method
Attendance to pre-allocated Lung Health Check Appointment	At an expected average of 1 year from the start of the study.	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of those invited eligible for screening.	At an expected average of 1 year from the start of the study.	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).
Smoking data of those attending.	At an expected average of 1 year from the start of the study.	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).
Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening.	At an expected average of 1 year from the start of the study.	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).
Uptake of CT scans and willingness to be screening	At an expected average of 1 year from the start of the study.	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).
Mortality	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.
Demographics of all those invited.	At an expected average of 1 year from the start of the study.	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).
Data on lung cancer risk of those attending.	At an expected average of 1 year from the start of the study.	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).
Past medical and symptom history of those attending.	At an expected average of 1 year from the start of the study.	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).
Informed decision making	At an expected average of 18 months from the start of the study.	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).
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.
Psychological burden of screening	At an expected average of 18 months from the start of the study.	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).
Costs generated from screening	At an expected average of 2 years from the start of the study.

Trial Locations

Locations (1)

University College London Hospital NHS Trust; 🇬🇧 London, England, United Kingdom