Skip to content

Virtual Management of Lung Nodules

Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04892524
Enrollment
55
Registered
2021-05-19
Start date
2021-04-19
Completion date
2023-10-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Nodule, Multiple, Pulmonary Nodule, Solitary

Keywords

Pulmonary nodule, Lung nodule, Solitary pulmonary nodule, Lung cancer, Virtual clinic

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.

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)

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

Sponsors

Southern Adelaide Local Health Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Cost6 monthsEconomic 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.

Secondary

MeasureTime frameDescription
Participant satisfaction6 monthsParticipant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)
Anxiety6 monthsParticipant 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026