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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01344005
• Other study ID #: CDR0000699222
• Secondary ID: WCTU-EL-CIDEU-21
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2011
• Last updated: August 23, 2013
• Start date: June 2011

Study information

• Verified date: April 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 386
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Tobacco Use Disorder

Intervention

Other:
• caregiver-related intervention or procedure

• questionnaire administration

Procedure:
• quality-of-life assessment

• radiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wales Cancer Trials Unit

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of extra-NICE symptoms in patients consulting in UK general practice			No
Primary	Proportion of patients who agree to participate in the trial			No
Primary	Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers			No
Secondary	Best way to train general practitioners to identify and recruit eligible patients into the trial			No
Secondary	Most effective method of presenting the trial (and randomization) to patients			No
Secondary	Barriers to recruitment and how to overcome those barriers			No
Secondary	Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays			No
Secondary	Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'			No
Secondary	Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer			No
Secondary	False-positive and false-negative rates for chest x-rays			No