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Lung CancerNCT01344005

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

A study testing caregiver-related intervention or procedure, questionnaire administration and quality-of-life assessment in people with Lung Cancer and Tobacco Use Disorder, run by Wales Cancer Trials Unit.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Lung Cancer, Tobacco Use Disorder
What is being tested?
caregiver-related intervention or procedure, questionnaire administration and quality-of-life assessment
Type of treatment
Surgery or procedure
How many people
386 participants
Where
No sites listed yet
Study dates
Jun 2011to Jun 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Read the 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.

Being tested
caregiver-related intervention or procedure, questionnaire administration, quality-of-life assessment, radiography
Keywords
non-small cell lung cancer, small cell lung cancer, tobacco use disorder
Medical subject headings
Lung Neoplasms, Tobacco Use Disorder, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • caregiver-related intervention or procedureOther

  • questionnaire administrationOther

  • quality-of-life assessmentProcedure or surgery

  • radiographyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Proportion of patients who agree to participate in the trial

  3. Proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers

Secondary outcomes (7)

  1. Best way to train general practitioners to identify and recruit eligible patients into the trial

  2. Most effective method of presenting the trial (and randomization) to patients

  3. Barriers to recruitment and how to overcome those barriers

  4. Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays

  5. Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'

  6. Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer

  7. False-positive and false-negative rates for chest x-rays

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Masking
None (open label)
Enrolment
386 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01344005
Sponsor's protocol ID
CDR0000699222
Other IDs
WCTU-EL-CID, EU-21112, CRUK-C8350/A12199
Status last verified
Apr 2011
First submitted
27 Apr 2011
Last updated
26 Aug 2013
Results posted
No

Publications

  • Prout H, Tod A, Neal R, Nelson A. Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis-staff insights from an embedded qualitative study. Trials. 2022 Mar 21;23(1):225. doi: 10.1186/s13063-022-06125-y.

    PubMed 35313926

  • Prout HC, Barham A, Bongard E, Tudor-Edwards R, Griffiths G, Hamilton W, Harrop E, Hood K, Hurt CN, Nelson R, Porter C, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Neal RD, Nelson A. Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study. Trials. 2018 Aug 4;19(1):419. doi: 10.1186/s13063-018-2803-4.

    PubMed 30075741

  • Neal RD, Barham A, Bongard E, Edwards RT, Fitzgibbon J, Griffiths G, Hamilton W, Hood K, Nelson A, Parker D, Porter C, Prout H, Roberts K, Rogers T, Thomas-Jones E, Tod A, Yeo ST, Hurt CN. Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial. Br J Cancer. 2017 Jan;116(3):293-302. doi: 10.1038/bjc.2016.414. Epub 2017 Jan 10.

    PubMed 28072761

  • Hurt CN, Roberts K, Rogers TK, Griffiths GO, Hood K, Prout H, Nelson A, Fitzgibbon J, Barham A, Thomas-Jones E, Edwards RT, Yeo ST, Hamilton W, Tod A, Neal RD. A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial. Trials. 2013 Nov 26;14:405. doi: 10.1186/1745-6215-14-405.

    PubMed 24279296

Questions about this trial

What is this clinical trial studying?

A study testing caregiver-related intervention or procedure, questionnaire administration and quality-of-life assessment in people with Lung Cancer and Tobacco Use Disorder, run by Wales Cancer Trials Unit.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of extra-NICE symptoms in patients consulting in UK general practice. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344005, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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