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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01344005
First received: April 27, 2011
Last updated: August 23, 2013
Last verified: April 2011
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344005

Sponsors and Collaborators
Wales Cancer Trials Unit
Investigators
Principal Investigator: Richard Neal, MD North Wales Clinical School
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 23, 2013
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014