Clinical trial · Interventional

Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years

A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms

NCT01344005CI-TRIAL-00011881unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years. PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Tobacco Use Disorder	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
caregiver-related intervention or procedure	Other	—	UNRESOLVED
quality-of-life assessment	Procedure	—	UNRESOLVED
questionnaire administration	Other	—	UNRESOLVED
radiography	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
Prevalence of extra-NICE symptoms in patients consulting in UK general practice
measure
Proportion of patients who agree to participate in the trial
measure
Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers

Secondary outcomes (7)

measure
Best way to train general practitioners to identify and recruit eligible patients into the trial
measure
Most effective method of presenting the trial (and randomization) to patients
measure
Barriers to recruitment and how to overcome those barriers
measure

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 60 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Patients over 60 seeing a participating General Practitioner
* Currently smokes 10 or more pack years, meeting at least one of the following criteria:

  * New or altered cough of any duration reported to primary care
  * Increased breathlessness or wheezing (with or without purulent sputum)
* Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent \[lasting \> 3 weeks\] signs or symptoms), including having any of the following:

  * Cough
  * Chest/shoulder pain
  * Dyspnea
  * Weight loss
  * Chest signs
  * Hoarseness
  * Finger clubbing
  * Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin)
  * Cervical/supraclavicular lymphadenopathy

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No chest x-ray within in past 3 months
* No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics

References

Publications (4)

DERIVEDProut H, Tod A, Neal R, Nelson A. Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis-staff insights from an embedded qualitative study. Trials. 2022 Mar 21;23(1):225. doi: 10.1186/s13063-022-06125-y. PMID 35313926
DERIVEDProut HC, Barham A, Bongard E, Tudor-Edwards R, Griffiths G, Hamilton W, Harrop E, Hood K, Hurt CN, Nelson R, Porter C, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Neal RD, Nelson A. Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study. Trials. 2018 Aug 4;19(1):419. doi: 10.1186/s13063-018-2803-4. PMID 30075741
DERIVEDNeal RD, Barham A, Bongard E, Edwards RT, Fitzgibbon J, Griffiths G, Hamilton W, Hood K, Nelson A, Parker D, Porter C, Prout H, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Hurt CN. Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial. Br J Cancer. 2017 Jan;116(3):293-302. doi: 10.1038/bjc.2016.414. Epub 2017 Jan 10. PMID 28072761
DERIVEDHurt CN, Roberts K, Rogers TK, Griffiths GO, Hood K, Prout H, Nelson A, Fitzgibbon J, Barham A, Thomas-Jones E, Edwards RT, Yeo ST, Hamilton W, Tod A, Neal RD. 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. Trials. 2013 Nov 26;14:405. doi: 10.1186/1745-6215-14-405. PMID 24279296