CClinicalTrials.gg
Status unknownNCT04892524Updated Sep 21, 2022

Virtual Management of Lung Nodules

An interventional study of Virtual multidisciplinary review in Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, sponsored by Southern Adelaide Local Health Network. Status unknown at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Southern Adelaide Local Health Network · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Initial Steps:

  1. Individuals that have been referred to the Respiratory Outpatient Department of Flinders Medical Centre for management of a lung nodule will have their referral data screened by a doctor to determine that the referral meets criteria for management in the outpatient department and which category of follow-up is required (triaging process).
  2. Eligible referrals will be provided to the study's research assistant who will contact the individual to discuss the study in detail and obtain consent to participate.
  3. Individuals that have consented to participate are randomly assigned to either the 'virtual model' of lung nodule management (a), or the 'face-to-face model' of lung nodule management (b). Each participant has a 50% chance (1 in 2) of being assigned to either group.

    1. The 'virtual model' involves participants' CT scan(s) being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse these scans and make a recommendation for any follow-up scans, procedures or appointments that may be required. The team will contact each participant with a phone-call. Participants primary care providers will also receive a letter describing the review and plan. Participants are not required to physically attend the hospital or outpatient department for this review to occur.
    2. The 'face-to-face model' involves a face-to-face appointment in the Respiratory outpatient clinic at Flinders Medical Centre, where a doctor will review participants' CT scan(s) and make a plan for any follow-up scans, procedures or appointments that may be required. Primary care providers will be informed of the outcome of this visit. Participants are required to physically attend the clinic appointment for this review.

All participants in this research study will be asked to complete an initial set of two questionnaires. The questionnaires include:

  • Participant information questionnaire - collects personal information and contact details, as well as specific health-related, occupational and lifestyle information.
  • Hospital Anxiety and Depression Scale (HADS)

Once participants have had their face-to-face appointment or virtual review, they will be asked to complete four questionnaires at a 1-month and 3-month interval. The questionnaires include:

  • Hospital Anxiety and Depression Scale (HADS)
  • Patient experience questionnaire
  • Patient economic impact questionnaire
  • Modified Visit-specific satisfaction instrument (VSQ-9)
02

Conditions studied

  • Pulmonary Nodule, Solitary
  • Pulmonary Nodule, Multiple

Keywords

  • Pulmonary nodule
  • Lung nodule
  • Solitary pulmonary nodule
  • Lung cancer
  • Virtual clinic
03

In context

Multiple Pulmonary Nodules

188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.

This study's planned enrollment of 55 is below the median of 88 across 97 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

This is the only study on the registry with Southern Adelaide Local Health Network as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Virtual multidisciplinary review

    Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team

    Other: Virtual multidisciplinary review

  • No intervention
    Face-to-face review

    Participants in this group will be reviewed in a face-to-face clinic

Interventions

  • OtherVirtual 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

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Participant satisfaction

    Participant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)

    Time frame: 6 months

  2. Anxiety

    Participant anxiety as measure by the Hospital Anxiety and Depression Scale (HADS), which is a questionnaire containing seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    Time frame: 6 months

07

Study locations

1 site
  • Flinders Medical Centre
    Bedford Park, South Australia 5042, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04892524
Lead sponsor
Southern Adelaide Local Health Network
Responsible party
Sponsor
First posted
May 19, 2021
Start date
Apr 19, 2021
Primary completion
May 30, 2022
Completion
Oct 2023 (estimated)
Last update
Sep 21, 2022

Study contacts

Anand Rose
principal investigator · Southern Adelaide Local Health Network

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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