Pulmonary Nodule, SolitaryNCT04892524
Virtual Management of Lung Nodules
A study testing Virtual multidisciplinary review in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Southern Adelaide Local Health Network at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Solitary, Pulmonary Nodule, Multiple
- What is being tested?
- Virtual multidisciplinary review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Apr 2021to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- Virtual multidisciplinary review
- Keywords
- Pulmonary nodule, Lung nodule, Solitary pulmonary nodule, Lung cancer, Virtual clinic
- Medical subject headings
- Solitary Pulmonary Nodule, Multiple Pulmonary Nodules, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual multidisciplinary reviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual multidisciplinary review | Experimental | Participants in this arm will be reviewed in a virtual clinic by a multidisciplinary team Receives: Other: Virtual multidisciplinary review |
| Face-to-face review | No intervention | Participants in this group will be reviewed in a face-to-face clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
Participant satisfaction
Participant satisfaction, measured by the Visit-Specific Satisfaction Instrument (VSQ-9)
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start19 Apr 2021
- Primary completion30 May 2022
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Adelaide Local Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anand Rose, Principal investigator, Southern Adelaide Local Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892524
- Sponsor's protocol ID
- SALHNLungNodules
- Status last verified
- Sep 2022
- First submitted
- 7 May 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Identification, Management and Follow-up of Incidental Lung Nodules.
- ClinicalTrials.gov ID
- NCT04892524
- Acronym / sponsor ID
- SALHNLungNodules
- Keywords
- Pulmonary nodule, Lung nodule, Solitary pulmonary nodule, Lung cancer, Virtual clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Southern Adelaide Local Health NetworkUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- Oct 2023 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual multidisciplinary review | Experimental | Other: Virtual multidisciplinary reviewParticipants in this arm will be reviewed in a virtual clinic by a multidisciplinary team |
| Face-to-face review | No intervention | –Participants in this group will be reviewed in a face-to-face clinic |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual multidisciplinary reviewThe 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 | Other | Virtual multidisciplinary review |
Primary outcome
Cost
Time frame: 6 months
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.
2 secondary outcomes
Participant satisfaction
Time frame: 6 months
Anxiety
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anand Rose principal investigator
Southern Adelaide Local Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual multidisciplinary review in people with Pulmonary Nodule, Solitary and Pulmonary Nodule, Multiple, run by Southern Adelaide Local Health Network at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.