NCT01344005Unknown不适用
A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms
Wales Cancer Trials Unit0 个研究点目标入组 386 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 386
- 主要终点
- Prevalence of extra-NICE symptoms in patients consulting in UK general practice
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Chest/shoulder pain
- •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
排除标准
- 未提供
结局指标
主要结局
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
次要结局
- 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
研究者
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