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

NCT01344005 | Unknown

• 4 other identifiers: CDR0000699222WCTU-EL-CIDEU-21112CRUK-C8350/A12199
• Study Type: interventional
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer; Tobacco Use Disorder

Keywords

non-small cell lung cancer; small cell lung cancer; tobacco use disorder

Outcome Measures

Primary Outcomes (3)

• Prevalence of extra-NICE symptoms in patients consulting in UK general practice

• Proportion of patients who agree to participate in the trial

• Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers

Secondary Outcomes (7)

• Best way to train general practitioners to identify and recruit eligible patients into the trial

• Most effective method of presenting the trial (and randomization) to patients

• Barriers to recruitment and how to overcome those barriers

• Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays

• Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'

Interventions

caregiver-related intervention or procedure OTHER

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

radiography PROCEDURE

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wales Cancer Trials Unit: lead

Related Publications (4)

• Prout 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 DERIVED

• Prout 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 DERIVED

• Neal 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 DERIVED

• Hurt 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 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Tobacco Use Disorder; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Richard Neal, MD

  North Wales Clinical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2011-04