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Completed

NCT Number: NCT02558101

Lung Screen Uptake Trial

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospital NHS Trust

London, England, NW1 2BU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control invitation materials

Behavioral

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

Intervention invitation materials

Behavioral

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.

Primary outcomes

  1. Attendance to pre-allocated Lung Health Check Appointment

    Time frame: 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 outcomes

  1. Demographics of all those invited.

    Time frame: 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).

  2. Smoking data of those attending.

    Time frame: 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).

  3. Data on lung cancer risk of those attending.

    Time frame: 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).

  4. Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening.

    Time frame: 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).

  5. Past medical and symptom history of those attending.

    Time frame: 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).

  6. Proportion of those invited eligible for screening.

    Time frame: 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).

  7. Uptake of CT scans and willingness to be screening

    Time frame: 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).

  8. Psychological burden of screening

    Time frame: 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).

  9. Informed decision making

    Time frame: 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).

  10. Radiological and clinical outcomes of those screened

    Time frame: At an expected average of 2 years from the start of the study.

  11. Numbers of investigations generated from screening

    Time frame: At an expected average of 2 years from the start of the study.

  12. Costs generated from screening

    Time frame: At an expected average of 2 years from the start of the study.

  13. Adverse events

    Time frame: At an expected average of 2 years from the start of the study.

  14. Mortality

    Time frame: At an expected average of 2 years from the start of the study.

Other outcomes

  1. Tissue bank of biological samples from a high risk cohort

    Time frame: At an expected average of 1 year from the start of the study.

    This will be collected at 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).

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Homerton University Hospital NHS Foundation Trust
  • University College London Hospitals

Registry information

Official study 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

Acronym: Lung-SCREEN

Important dates

Study start
2015
Primary completion
2017
Study completion
2022
First posted
Sep 23, 2015
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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