Virtual Management of Lung Nodules

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple
• Intervention / Treatment: Other: Virtual multidisciplinary review

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)

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual multidisciplinary review; Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team	Other: 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
No Intervention: Face-to-face review; Participants in this group will be reviewed in a face-to-face clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Participant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)	6 months
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.	6 months

Collaborators and Investigators

• Sponsor: Southern Adelaide Local Health Network
• Investigators: Principal Investigator: Anand Rose, Southern Adelaide Local Health Network

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): May 30, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Lung cancer; Lung nodule; Virtual clinic; Pulmonary nodule; Solitary pulmonary nodule
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: SALHNLungNodules

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No