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

Christopher N Hurt, Kirsty Roberts, Trevor K Rogers, Gareth O Griffiths, Kerry Hood, Hayley Prout, Annmarie Nelson, Jim Fitzgibbon, Allan Barham, Emma Thomas-Jones, Rhiannon Tudor Edwards, Seow Tien Yeo, William Hamilton, Angela Tod, Richard D Neal, Christopher N Hurt, Kirsty Roberts, Trevor K Rogers, Gareth O Griffiths, Kerry Hood, Hayley Prout, Annmarie Nelson, Jim Fitzgibbon, Allan Barham, Emma Thomas-Jones, Rhiannon Tudor Edwards, Seow Tien Yeo, William Hamilton, Angela Tod, Richard D Neal

Abstract

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.

Figures

Figure 1
Figure 1
Thresholds for referral for chest X-ray.
Figure 2
Figure 2
Trial schema.

References

    1. Cancer Research UK. CancerStats: Cancer Statistics for the UK.
    1. Office for National Statistics. Deaths Registered in England and Wales in 2010, by Cause. 2011. (Office for National Statistics Statistical Bulletin).
    1. Berrino F, De Angelis R, Sant M, Rosso S, Bielska-Lasota M, Coebergh JW, Santaquilani M. EUROCARE: Working group Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995–99: results of the EUROCARE-4 study. Lancet Oncol. 2007;8(9):773–783. doi: 10.1016/S1470-2045(07)70245-0.
    1. Imperatori A, Harrison RN, Leitch DN, Rovera F, Lepore G, Dionigi G, Sutton P, Dominioni L. Lung cancer in Teesside (UK) and Varese (Italy): a comparison of management and survival. Thorax. 2006;61(3):232–239. doi: 10.1136/thx.2005.040477.
    1. Fry WA, Phillips JL, Menck HR. Ten-year survey of lung cancer treatment and survival in hospitals in the United States: a national cancer data base report. Cancer. 1999;86(9):1867–1876. doi: 10.1002/(SICI)1097-0142(19991101)86:9<1867::AID-CNCR31>;2-9.
    1. Janssen-Heijnen ML, Gatta G, Forman D, Capocaccia R, Coebergh JW. Variation in survival of patients with lung cancer in Europe, 1985–1989. Eur J Cancer. 1998;34(14):2191–2196. doi: 10.1016/S0959-8049(98)00312-8.
    1. Richards MA. The size of the prize for earlier cancer diagnosis of cancer in England. Brit J Cancer. 2009;101:s125–s129.
    1. Abdel-Rahman M, Stockton D, Rachet D, Hakulinen T, Coleman MP. What if cancer survival in Britain were the same as in Europe: how many deaths are avoidable? Brit J Cancer. 2009;101:s115–s124.
    1. Moller H, Linklater KM, Robinson D. A visual summary of the EUROCARE-4 results: a UK perspective. Brit J Cancer. 2009;101:s110–s114.
    1. Barrett J, Hamilton W. Pathways to the diagnosis of lung cancer in the UK: a cohort study. BMC Family Prac. 2008;9:31. doi: 10.1186/1471-2296-9-31.
    1. National Collaborating Centre for Chronic Conditions. Chronic obstructive pulmonary disease: National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax. 2004;59(Suppl 1):1–232.
    1. Corner J, Hopkinson J, Fitzsimmons D, Barclay S, Muers M. Is late diagnosis of lung cancer inevitable? Interview study of patients’ recollections of symptoms before diagnosis. Thorax. 2005;60(4):314–319. doi: 10.1136/thx.2004.029264.
    1. Hamilton W, Peters TJ, Round A, Sharp D. What are the clinical features of lung cancer before the diagnosis is made? A population based case–control study. Thorax. 2005;60(12):1059–1065. doi: 10.1136/thx.2005.045880.
    1. Allgar VL, Neal RD. Delays in the diagnosis of six cancers: analysis of data from the national survey of NHS patients: cancer. Brit J Cancer. 2005;92(11):1959–1970. doi: 10.1038/sj.bjc.6602587.
    1. Allgar VL, Neal RD. General practitioners’ management of cancer in England: secondary analysis of data from the National Survey of NHS Patients-Cancer. Eur J Cancer Care. 2005;14(5):409–416. doi: 10.1111/j.1365-2354.2005.00600.x.
    1. Tod AM, Craven J, Allmark P. Diagnostic delay in lung cancer: a qualitative study. J Advanced Nursing. 2008;61(3):336–343. doi: 10.1111/j.1365-2648.2007.04542.x.
    1. Allgar VL, Neal RD, Ali N, Leese B, Heywood P, Proctor G, Evans J. Urgent GP referrals for suspected lung, colorectal, prostate and ovarian cancer. Brit J Gen Prac. 2006;56(526):355–362.
    1. Neal RD, Allgar VL, Ali N, Leese B, Heywood P, Proctor G, Evans J. Stage, survival and delays in lung, colorectal, prostate and ovarian cancer: comparison between diagnostic routes. Brit J Gen Prac. 2007;57(536):212–219.
    1. Neal RD. Do diagnostic delays in cancer matter? Brit J Cancer. 2009;101:S9–S12.
    1. Fontana RS, Sanderson DR, Taylor WF, Woolner LB, Miller WE, Muhm JR, Uhlenhopp MA. Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Mayo Clinic Study. Am Rev Respiratory Dis. 1984;130(4):561–565.
    1. Kubik A, Polak J. Lung cancer detection. Results of a randomized prospective study in Czechoslovakia. Cancer. 1986;57(12):2427–2437. doi: 10.1002/1097-0142(19860615)57:12<2427::AID-CNCR2820571230>;2-M.
    1. Frost JK, Ball WC Jr, Levin ML, Tockman MS, Baker RR, Carter D, Eggleston JC, Erozan YS, Gupta PK, Khouri NF. Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Johns Hopkins study. Am Rev Respiratory Dis. 1984;130(4):549–554.
    1. Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, Crawford ED, Fouad MN, Isaacs C, Reding DJ, Weissfeld JL, Yokochi LA, O’Brien B, Ragard LR, Rathmell JM, Riley TL, Wright P, Caparaso N, Hu P, Izmirlian G, Pinsky PF, Prorok PC, Kramer BS, Miller AB, Gohagan JK, Berg CD. Plco Project Team. Screening By chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. JAMA. 2011;306(17):1865–1873. doi: 10.1001/jama.2011.1591.
    1. Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. p. 395.
    1. Veronesi G, Maisonneuve P, Bellomi M, Rampinelli C, Durli I, Bertolotti R, Spaggiari R. Estimating overdiagnosis in low-dose computed tomography screening for lung cancer: a cohort study. Ann Int Med. 2012;157(11):776–784. doi: 10.7326/0003-4819-157-11-201212040-00005.
    1. Black WC. Cost Effectiveness of Screening in the National Lung Screening Trial. .
    1. Spiro SG. Screening for lung cancer: We still need to know more. Thorax. 2012;67:283–285. doi: 10.1136/thoraxjnl-2011-201541.
    1. Horeweg N, van der Aalst CM, Thunnissen E, Nackaerts K, Weenink C, Groen HJ, Lammers JW, Aerts JG, Scholten ET, van Rosmalen J, Mali W, Oudkerk M, de Koning HJ. Characteristics of lung cancers detected by computer tomography screening in the Randomized Nelson Trial. Am J Respiratory Crit Care Med. 2013;187(8):848–854. doi: 10.1164/rccm.201209-1651OC.
    1. Macdonald S, Macleod U, Mitchell E, Weller D, Campbell C, Mant D. Factors influencing patients and primary care delay in cancer: a database of existing research and implications for future practice. 2004. Final report to the Department of Health.
    1. Mansell G, Shapley M, Jordan JL, Jordan K. Interventions to reduce primary care delay in cancer referral: a systematic review. Brit J Gen Prac. 2011;61(593):e821. doi: 10.3399/bjgp11X613160.
    1. Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;16(10):67.
    1. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67(6):361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Coast J, Peters TJ, Natarajan L, Sproston K, Flynn T. An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people. Qual Life Res Int J Qual Life Aspects Treat Care Rehab. 2008;11:967–976.
    1. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I. Increasing response rates to postal questionnaires: systematic review. BMJ. 2010;324(7347):1183–1185.
    1. Edwards RT, Hounsome B, Linck P, Russell IT. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units. Trials. 2008;14:64–65.
    1. Ritchie J, Spencer L. In: Analyzing Qualitative Data. Bryman A, Burgess RG, editor. 2002. Qualitative data analysis for applied policy research; pp. 305–329.

Source: PubMed

3
구독하다