Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04892524




Registration number
NCT04892524
Ethics application status
Date submitted
7/05/2021
Date registered
19/05/2021
Date last updated
21/09/2022

Titles & IDs
Public title
Virtual Management of Lung Nodules
Scientific title
Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
Secondary ID [1] 0 0
SALHNLungNodules
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Nodule, Solitary 0 0
Pulmonary Nodule, Multiple 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Virtual multidisciplinary review

Experimental: Virtual multidisciplinary review - Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team

No intervention: Face-to-face review - Participants in this group will be reviewed in a face-to-face clinic


Other interventions: Virtual multidisciplinary review
The virtual multidisciplinary review involves participants being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse radiologic scans and make a recommendations for any follow-up scans, procedures or appointments that may be required
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cost
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Participant satisfaction
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Anxiety
Timepoint [2] 0 0
6 months

Eligibility
Key inclusion criteria
* Age 18-80 years
* At least 1 IPN identified on CT imaging measuring 4-30 mm in maximal diameter
* CT slice thickness of 3 mm or less
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous diagnosis of lung cancer
* History of haemoptysis
* Unexplained weight loss > 7 kg in the preceding 12 months
* Past history of malignancy within 5 years (excluding non-melanoma skin cancer)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Other
Name
Southern Adelaide Local Health Network
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study to determine how a virtual model for the management of lung nodules compares to a face-to-face clinic for patient satisfaction, quality of life and cost.
Trial website
https://clinicaltrials.gov/study/NCT04892524
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anand Rose
Address 0 0
Southern Adelaide Local Health Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04892524