Clinical trial NCT04892524: Virtual Management of Lung Nodules
Official title: Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Pulmonary Nodule, Multiple
Keywords: Pulmonary nodule
Lung nodule
Solitary pulmonary nodule
Lung cancer
Virtual clinic
Lead sponsor: Southern Adelaide Local Health Network
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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)

Eligibility criteria: 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)

Primary outcomes:
measure: Cost
timeFrame: 6 months
Secondary outcomes:
measure: Participant satisfaction
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
Study officials:
affiliation: Southern Adelaide Local Health Network
name: Anand Rose
role: PRINCIPAL_INVESTIGATOR
References: