Virtual Management of Lung Nodules

NCT ID: NCT04892524

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2023-10-31

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)

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual multidisciplinary review

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

Group Type: EXPERIMENTAL

Virtual multidisciplinary review

Intervention Type: OTHER

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

Face-to-face review

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern Adelaide Local Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anand Rose

Role: PRINCIPAL_INVESTIGATOR

Southern Adelaide Local Health Network

Locations

Flinders Medical Centre

Bedford Park, South Australia, Australia

Countries

Australia

Other Identifiers

SALHNLungNodules

Identifier Type: -

Identifier Source: org_study_id