Plain English Summary
Background and study aims
When compared to other common cancers, lung cancer patients are less likely to survive their cancer. This is often due to a delay in the recognition of the condition and performance of the chest X-ray (CXR). Delayed diagnosis reduces treatment choices because the cancer may have spread further and the person may have become too ill for treatment to be given safely. It is hoped that by diagnosing lung cancer sooner this will help improve survival, help with patient satisfaction and potentially extend the range of treatment options, which are more limited in delayed diagnosis. CXRs are often used when lung cancer is suspected, but there can be long delays for the results to be available to the patient and the GP. Radiographers traditionally take the X-ray, but they are reported by a radiologist, a medical specialist. Recent studies show that radiographers who have completed further training can report CXRs with similar accuracy to radiologists. This project will help to reduce delays in diagnosis for lung cancer in two ways. First, a trial of immediate reporting of GP requested CXRs may help to reduce delays and allow further tests to be performed sooner. Second, it is hoped having quicker access to results will reduce the number of patients who need to see a specialist. This should both reduce specialist referrals and anxiety. Based on previous work, so that patients have the best information about their care, and are able to make informed decisions, have constructed an information leaflet which will be distributed to general practitioners. This will be given to patients when they are referred for a CXR, explaining that further tests may be required, and some of the reasons for this. Hopefully this will help to reduce patient anxiety and give them insight into the pathway.
Who can participate?
Adults aged 16 and older who are referred for a chest x-ray.
What does the study involve?
Participants are randomly allocated to one of two groups using block randomisation at session (half day level). Those in the first group receive immediate reporting of chest X-rays referred by general practice, with CT chest when indicated. Those in the second group receive the standard level of care. This includes the routine reporting of chest X-rays referred by general practice. Participants are followed up to see how long it takes to diagnose lung cancer or how long it took to be discharged from the lung cancer pathway and to evaluate the effectiveness of immediate reporting of chest X-rays by general practice.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Hometon University Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2016 to January 2019
Who is funding the study?
Cancer Research UK (UK)
Who is the main contact?
Mr Nick Woznitza (Public)
nicholas.woznitza@nhs.net
Trial website
Contact information
Type
Public
Primary contact
Mr Nick Woznitza
ORCID ID
http://orcid.org/0000-0001-9598-189X
Contact details
Radiology Department
Homerton University Hopsital
Homerton Row
London
E9 6SR
United Kingdom
+44 208 510 5315
nicholas.woznitza@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
34539
Study information
Scientific title
Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway
Acronym
radioX
Study hypothesis
Immediate reporting of chest X-rays from general practice will reduce the time to diagnosis of lung cancer.
Ethics approval
London – Brent REC, 05/06/2017, ref: 17/LO/0870
Study design
Randomised; Interventional; Design type: Diagnosis, Process of Care, Imaging
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Health services and delivery research, Primary sub-specialty: Health Services and Delivery Research; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs, Respiratory/ Other diseases of the respiratory system
Intervention
Participants are randomly allocated to one of two groups using block randomisation at session (half day level).
Group 1: Participants receive immediate reporting of chest X-rays referred by general practice, with CT chest when indicated.
Group 2: Participants receive the standard level of care. This includes the routine reporting of chest X-rays referred by general practice.
Participants are followed up to see how long it takes to diagnose lung cancer or how long it took to be discharged from the lung cancer pathway and to evaluate the effectiveness of immediate reporting of chest X-rays by general practice.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Time (in days) to decision to treat (with intermediate time points) for lung cancer or discharge from the lung cancer pathway is measured using patient records at the time where there is a decision to treat or to be discharged from the lung cancer pathway.
Secondary outcome measures
1. Number of CT scans requested is measured using the number of CT chest scans through Radiology Information System at study completion
2. Survival is measured using aggregate data from cancer waiting time reporting at six and 12 months
3. Emergency admissions are measured using data from cancer waiting time reporting at study completion
4. Performance status is measured using data from cancer waiting time reporting at time of decision to treat
5. Number of urgent respiratory cancer referrals are measured from respiratory department records at study completion
6. Relative accuracy and usefulness of chest X-rays reporting by radiographers and consultant radiologists are measured using index diagnosis of thoracic radiologist and/or CT chest within 2 weeks of chest X-ray
7. Number of first 2WW appointments with all radiology results measured using clinician recorded data at time of appointment
8. Cost-effectiveness is measured using QALYS (Quality adjusted life years) at study completion
9. Patient satisfaction is measured using patient questionnaires at two weeks after chest x-ray
Overall trial start date
11/07/2016
Overall trial end date
30/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients referred for a chest X-ray from general practice
2. Over 16 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 4000; UK Sample Size: 4000
Participant exclusion criteria
1. Active diagnosis of lung cancer
2. Aged under 16 years
3. Chest X-rays referrals from any other practitioner (Emergency Department, Inpatient, Outpatient)
Recruitment start date
01/07/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hometon University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom
Funders
Funder type
Government
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Trial protocol to be submitted for peer review August 2017. Final results planned publication in a high-impact peer reviewed journal June 2019.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
31/07/2020
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in ncbi.nlm.nih.gov/pubmed/29110698 (added 12/12/2019)
2019 primary outcome report in https://doi.org/10.1016/S0169-5002(19)30073-X (added 12/12/2019)