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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


N/A
60 Years
N/A
Not Enrolling
Both
Lung Cancer, Tobacco Use Disorder

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Prevalence of extra-NICE symptoms in patients consulting in UK general practice

Safety Issue:

No

Principal Investigator

Richard Neal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Wales Clinical School

Authority:

Unspecified

Study ID:

CDR0000699222

NCT ID:

NCT01344005

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Lung Cancer
  • Tobacco Use Disorder
  • non-small cell lung cancer
  • small cell lung cancer
  • tobacco use disorder
  • Lung Neoplasms
  • Tobacco Use Disorder

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