A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial.
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BACKGROUND: In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. METHODS/DESIGN: We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. DISCUSSION: This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. TRIAL REGISTRATION: Clinicaltrials.gov NCT01344005.
This trial is funded by the National Awareness and Early Diagnosis Initiative (NAEDI) Research Call Funding Partners (in alphabetical order): Cancer Research UK (trial reference: C8350/A12199); Department of Health, England; Economic and Social Research Council; Health and Social Care Research and Development Division, Public Health Agency, Northern Ireland; National Institute for Social Care and Health Research, Wales; and the Scottish Government (http://www.naedi.org.uk). The trial has been developed on behalf of the NCRI Primary Care and Lung Clinical Studies Groups. It has been sponsored by Bangor University. The Wales Cancer Trials Unit is funded by Cancer Research UK. The South East Wales Trials Unit is funded by the National Institute for Health and Social Care Research (NISCHR).
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Vol. 14, pp. 405 -
Place of publication