Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer Tobacco Use Disorder |
Other: caregiver-related intervention or procedure Other: questionnaire administration Procedure: quality-of-life assessment Procedure: radiography |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms |
- Prevalence of extra-NICE symptoms in patients consulting in UK general practice [ Designated as safety issue: No ]
- Proportion of patients who agree to participate in the trial [ Designated as safety issue: No ]
- Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers [ Designated as safety issue: No ]
- Best way to train general practitioners to identify and recruit eligible patients into the trial [ Designated as safety issue: No ]
- Most effective method of presenting the trial (and randomization) to patients [ Designated as safety issue: No ]
- Barriers to recruitment and how to overcome those barriers [ Designated as safety issue: No ]
- Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays [ Designated as safety issue: No ]
- Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE' [ Designated as safety issue: No ]
- Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer [ Designated as safety issue: No ]
- False-positive and false-negative rates for chest x-rays [ Designated as safety issue: No ]
| Estimated Enrollment: | 386 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01344005 History of Changes |
| Other Study ID Numbers: | CDR0000699222, WCTU-EL-CID, EU-21112, CRUK-C8350/A12199 |
| Study First Received: | April 27, 2011 |
| Last Updated: | April 27, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
non-small cell lung cancer small cell lung cancer tobacco use disorder |
Additional relevant MeSH terms:
|
Lung Neoplasms Tobacco Use Disorder Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013