Skip to main content
Top
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2013

Login to get access

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
Appendix
Available only for authorised users
Literature
2.
go back to reference Office for National Statistics: Office for National Statistics Statistical Bulletin. Deaths Registered in England and Wales in 2010, by Cause. 2011 Office for National Statistics: Office for National Statistics Statistical Bulletin. Deaths Registered in England and Wales in 2010, by Cause. 2011
3.
go back to reference 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. 10.1016/S1470-2045(07)70245-0.CrossRefPubMed 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. 10.1016/S1470-2045(07)70245-0.CrossRefPubMed
4.
go back to reference 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. 10.1136/thx.2005.040477.CrossRefPubMed 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. 10.1136/thx.2005.040477.CrossRefPubMed
5.
go back to reference 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. 10.1002/(SICI)1097-0142(19991101)86:9<1867::AID-CNCR31>3.0.CO;2-9.CrossRefPubMed 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. 10.1002/(SICI)1097-0142(19991101)86:9<1867::AID-CNCR31>3.0.CO;2-9.CrossRefPubMed
6.
go back to reference 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. 10.1016/S0959-8049(98)00312-8.CrossRefPubMed 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. 10.1016/S0959-8049(98)00312-8.CrossRefPubMed
8.
go back to reference 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.CrossRefPubMedPubMedCentral 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.CrossRefPubMedPubMedCentral
10.
go back to reference Barrett J, Hamilton W: Pathways to the diagnosis of lung cancer in the UK: a cohort study. BMC Family Prac. 2008, 9: 31-10.1186/1471-2296-9-31.CrossRef Barrett J, Hamilton W: Pathways to the diagnosis of lung cancer in the UK: a cohort study. BMC Family Prac. 2008, 9: 31-10.1186/1471-2296-9-31.CrossRef
11.
go back to reference 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. 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.
12.
go back to reference 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. 10.1136/thx.2004.029264.CrossRefPubMedPubMedCentral 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. 10.1136/thx.2004.029264.CrossRefPubMedPubMedCentral
13.
go back to reference 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. 10.1136/thx.2005.045880.CrossRefPubMedPubMedCentral 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. 10.1136/thx.2005.045880.CrossRefPubMedPubMedCentral
14.
go back to reference 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. 10.1038/sj.bjc.6602587.CrossRefPubMedPubMedCentral 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. 10.1038/sj.bjc.6602587.CrossRefPubMedPubMedCentral
15.
go back to reference 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. 10.1111/j.1365-2354.2005.00600.x.CrossRef 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. 10.1111/j.1365-2354.2005.00600.x.CrossRef
16.
go back to reference Tod AM, Craven J, Allmark P: Diagnostic delay in lung cancer: a qualitative study. J Advanced Nursing. 2008, 61 (3): 336-343. 10.1111/j.1365-2648.2007.04542.x.CrossRef Tod AM, Craven J, Allmark P: Diagnostic delay in lung cancer: a qualitative study. J Advanced Nursing. 2008, 61 (3): 336-343. 10.1111/j.1365-2648.2007.04542.x.CrossRef
17.
go back to reference 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. 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.
18.
go back to reference 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. 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.
20.
go back to reference 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.PubMed 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.PubMed
21.
go back to reference Kubik A, Polak J: Lung cancer detection. Results of a randomized prospective study in Czechoslovakia. Cancer. 1986, 57 (12): 2427-2437. 10.1002/1097-0142(19860615)57:12<2427::AID-CNCR2820571230>3.0.CO;2-M.CrossRefPubMed Kubik A, Polak J: Lung cancer detection. Results of a randomized prospective study in Czechoslovakia. Cancer. 1986, 57 (12): 2427-2437. 10.1002/1097-0142(19860615)57:12<2427::AID-CNCR2820571230>3.0.CO;2-M.CrossRefPubMed
22.
go back to reference Frost JK, Ball WC, 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.PubMed Frost JK, Ball WC, 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.PubMed
23.
go back to reference 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. 10.1001/jama.2011.1591.CrossRefPubMed 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. 10.1001/jama.2011.1591.CrossRefPubMed
24.
go back to reference 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. 365 (5): 395- 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. 365 (5): 395-
25.
go back to reference 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. 10.7326/0003-4819-157-11-201212040-00005.CrossRefPubMed 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. 10.7326/0003-4819-157-11-201212040-00005.CrossRefPubMed
27.
go back to reference Spiro SG: Screening for lung cancer: We still need to know more. Thorax. 2012, 67: 283-285. 10.1136/thoraxjnl-2011-201541.CrossRefPubMed Spiro SG: Screening for lung cancer: We still need to know more. Thorax. 2012, 67: 283-285. 10.1136/thoraxjnl-2011-201541.CrossRefPubMed
28.
go back to reference 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. 10.1164/rccm.201209-1651OC.CrossRef 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. 10.1164/rccm.201209-1651OC.CrossRef
29.
go back to reference 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 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
30.
go back to reference 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): e821-10.3399/bjgp11X613160.CrossRef 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): e821-10.3399/bjgp11X613160.CrossRef
31.
go back to reference 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-CrossRef 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-CrossRef
32.
go back to reference Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983, 67 (6): 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983, 67 (6): 361-370. 10.1111/j.1600-0447.1983.tb09716.x.CrossRefPubMed
33.
go back to reference 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.CrossRef 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.CrossRef
34.
go back to reference 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.CrossRef 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.CrossRef
35.
go back to reference 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.CrossRef 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.CrossRef
36.
go back to reference Ritchie J, Spencer L: Qualitative data analysis for applied policy research. Analyzing Qualitative Data. Edited by: Bryman A, Burgess RG. 2002, 305-329. Ritchie J, Spencer L: Qualitative data analysis for applied policy research. Analyzing Qualitative Data. Edited by: Bryman A, Burgess RG. 2002, 305-329.
Metadata
Title
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
Authors
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
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-405

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue