Condition category
Cancer
Date applied
23/09/2015
Date assigned
23/09/2015
Last edited
31/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study is a randomised controlled trial to test novel invitation methods and materials designed to increase informed uptake of lung cancer screening in individuals at high risk of lung cancer. Lung cancer Low (radiation) Dose Computed Tomography (LDCT) screening has been shown to reduce the number of people who die of lung cancer and of all causes by picking lung cancer up at an earlier stage when treatment is more successful. Screening is now underway in various countries across the world. For the benefits of lung screening to clearly outweigh the harms, screening needs to be targeted at people who are at high risk. However multiple studies have shown that uptake is particularly poor in this group. Qualitative research in this area has highlighted some of the possible explanations for this. This has enabled the development of a novel method of approaching this target population. The aim of this study is is to compare lung screening uptake in people who are sent our new materials designed to improve uptake with people receiving more conventional materials.

Who can participate?
Adults aged 60 to 75 who are current smokers

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a lung health check invitation and those in the second group receive the standard care. Participants are followed up to see if participants attended the health check two weeks after receiving the invitation,.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
October 2014 to July 2018

Who is funding the study?
Cancer Research UK (UK)

Who is the main contact?
Dr Mamta Ruparel

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mamta Ruparel

ORCID ID

Contact details

Division of Medicine
5 University Street
London
WC1E 6JF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19480

Study information

Scientific 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

Study hypothesis

The aim of this study is to investigate the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment.

Ethics approval

First Medical Research Ethics Committee, 15/07/2015, ref: 15/LO/1186

Study design

Both; Interventional and Observational; Design type: Process of Care, Screening, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cancer; Subtopic: Lung Cancer; Disease: Lung (small cell)

Intervention

Patients are 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.

Control invitation materials: These are similar to standard materials used in other NHS screening programmes.

Targeted invitation materials: The intervention invitation materials are specifically designed and hypothesised to improve uptake to a pre-screening lung health check appointment.

Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Drug names

Primary outcome measures

Attendance to lung health check measured approximately 2 weeks post receipt of invitation.

Secondary outcome measures

1. Adverse eventsare monitored throughout the study in all participants
2. Demographics of attenders and non-attendersis determined at the initial primary care search
3. Eligibility, uptake and willingness for baseline screening scan measured at baseline (lung health check appointment)
4. Informed decision making measured at baseline lung health check appointment, the day after and 3 months after the appointment
5. Investigations and costs generated from screening determined at the end of study
6. Mortality and Survival rates determined at the end of study
7. Psychological burden of screening determined at baseline lung health check appointment, the day after and 3 months after the appointment
8. Radiological and clinical outcomes determined at the end of study
9. Smoking data, lung cancer risk and medical history determined at baseline (lung health check appointment)

Overall trial start date

01/10/2014

Overall trial end date

21/07/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 to 75 years
2. Recorded as a current smoker from 2010 or later

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2000; UK Sample Size: 2000; Description: A total of 2000 patients will be invited for a lung cancer screening appointment, 1000 in each arm. This will provide 90% power to detect a significant difference in uptake of 35% vs. 42%, with 5% significance level and two-sided testing. We estimate 35% uptake in the control group with a 7% increase in uptake in the intervention group based on similar studies examining the effect on screening uptake of ‘psycho-educational’ materials.

Participant exclusion criteria

1. Active diagnosis of lung cancer or metastases
2. CT thorax within the past year
3. Inability to consent to study
4. Palliative care register
5. GP's alert to co-morbidity that contraindicates screening or treatment for lung cancer

Recruitment start date

02/11/2015

Recruitment end date

07/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Medicine
Rayne Building 5 University Street
London
WC1E 6JF
United Kingdom

Sponsor information

Organisation

University College London Biomedical Research Unit

Sponsor details

Ground Floor
Rosenheim Wing
25 Grafton Way
London
WC1E 6BT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Cancer Research UK (NAEDI)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intent to publish date: around one year after end of recruitment date i.e. July 2018.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/07/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27098676

Publication citations

Additional files

Editorial Notes

31/08/2017: Plain English summary has been added. Individual patient level data sharing statement has been added. Publication and dissemination has been added. 18/07/2017: Updated recruitment end date from 31/03/2017 to 07/07/2017. Overall trial end date was updated from 30/06/2018 to 21/07/2018. 09/08/2016: Changed overall study start date from 01/09/2015 to 01/10/2014. Changed overall study end date from 01/09/2016 to 31/06/2018. Changed recruitment start date from 01/09/2015 to. Change recruitment end date from 02/11/2015 to 31/03/2017. 25/04/2016: Publication reference added.