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Virtual Management of Lung Nodules

Primary Purpose

Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Virtual multidisciplinary review
Sponsored by
Southern Adelaide Local Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pulmonary Nodule, Solitary focused on measuring Pulmonary nodule, Lung nodule, Solitary pulmonary nodule, Lung cancer, Virtual clinic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Flinders Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual multidisciplinary review

Face-to-face review

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 7, 2021
Last Updated
September 19, 2022
Sponsor
Southern Adelaide Local Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT04892524
Brief Title
Virtual Management of Lung Nodules
Official Title
Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Adelaide Local Health Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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). 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. 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. 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
Keywords
Pulmonary nodule, Lung nodule, Solitary pulmonary nodule, Lung cancer, Virtual clinic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual multidisciplinary review
Arm Type
Experimental
Arm Description
Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team
Arm Title
Face-to-face review
Arm Type
No Intervention
Arm Description
Participants in this group will be reviewed in a face-to-face clinic
Intervention Type
Other
Intervention Name(s)
Virtual multidisciplinary review
Intervention Description
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
Primary Outcome Measure Information:
Title
Cost
Description
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 Outcome Measure Information:
Title
Participant satisfaction
Description
Participant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)
Time Frame
6 months
Title
Anxiety
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Rose
Organizational Affiliation
Southern Adelaide Local Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Management of Lung Nodules

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