Lung Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic
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