Virtual Management of Lung Nodules
Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
1 other identifier
interventional
55
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2021
CompletedFirst Submitted
Initial submission to the registry
May 7, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedSeptember 21, 2022
September 1, 2022
1.1 years
May 7, 2021
September 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost
Economic cost to participants and our health service, measured by an investigator-derived questionnaire asking participants to describe time spent engaging in the their health care and any direct costs associated with visits. Economical modelling will also be applied to determine the staffing and resource costs associated with provision of care to participants in each arm.
6 months
Secondary Outcomes (2)
Participant satisfaction
6 months
Anxiety
6 months
Study Arms (2)
Virtual multidisciplinary review
EXPERIMENTALParticipants in this arm will be reviewed in a virtual clinic by a multidisciplinary team
Face-to-face review
NO INTERVENTIONParticipants in this group will be reviewed in a face-to-face clinic
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Rose
Southern Adelaide Local Health Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2021
First Posted
May 19, 2021
Study Start
April 19, 2021
Primary Completion
May 30, 2022
Study Completion
October 1, 2023
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share