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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To determine the prevalence of extra-NICE symptoms in patients consulting in UK general practice. To determine the proportion of patients who agree to participate in the trial. To determine the proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers. Secondary To determine the best way to train general practitioners to identify and recruit eligible patients into the trial. To determine the most effective method of presenting the trial (and randomization) to patients. To determine the barriers to recruitment and how to overcome those barriers. To determine the best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays. To determine the best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'. To determine the stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm A: Patients are managed as per the National Institute for Health and Clinical Excellence (NICE) guidelines. Arm B: Patients are referred for an urgent chest x-ray according to extra-NICE guidelines. General practitioners from South East Wales are surveyed to assess their level of interest in the proposed full trial. For the feasibility study, 20 South East Wales general practices and 6 South Yorkshire general practices are selected. General practitioners are trained to recruit all patients who fulfill the extra-NICE criteria as well as those who do not. Patients complete questionnaires (HADS, EQ-5D, and ICECAP[O]) at baseline and at 2 months to measure quality of life and health economic analysis of the cost-effectiveness of extra-NICE guidelines. Peer Reviewed and Funded or Endorsed by Cancer Research UK.

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

Conditions
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Lung Cancer, Tobacco Use Disorder

Intervention / Treatment
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* Other: caregiver-related intervention or procedure
* Other: questionnaire administration
* Procedure: quality-of-life assessment
* Procedure: radiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: caregiver-related intervention or procedure|nan|
|Other: questionnaire administration|nan|
|Procedure: quality-of-life assessment|nan|
|Procedure: radiography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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' |  |  | 
| Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer |  |  | 
| False-positive and false-negative rates for chest x-rays |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer, tobacco use disorder