Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000483550
Ethics application status
Approved
Date submitted
6/02/2024
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Support Tool for Low Risk Thyroid Cancer
Scientific title
Application of a clinical support tool in active surveillance for low risk thyroid cancer
Secondary ID [1] 311477 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid Cancer 332800 0
Condition category
Condition code
Cancer 329520 329520 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: We have developed a web-based clinical decision support tool that can assist a clinician in identifying whether their patient with low risk thyroid cancer may be appropriate for active surveillance. This tool will collect information then generate a result for the clinician as to whether the patient is suitable for active surveillance, based on the information entered into the tool. The tool will also provide a link to a document containing general information about the outcomes of active surveillance and surgery for treatment of low risk thyroid cancer, to help clinicians discuss these management options with their patients. Clinicians will access the tool that will be provided to them via a web-based link. The study will be open for recruitment for 3 years. The tool will be used in an outpatient clinical setting in the consulting rooms or clinics of participating clinicians. The tool is self-explanatory and does not require any training. It will take approximately 5-10 minutes to input information and generate a result. Each involved study site has signed a clinical trial research agreement indicating they will adhere to the tool. Patient information that will be collected by the tool includes: age, presence of comorbidities that may preclude them from surgical management, patient willingness to consider active surveillance and whether the clinician thinks the patient would be reliable to attend follow up.
Intervention code [1] 327932 0
Treatment: Other
Comparator / control treatment
Control: We have developed a control web based tool that collects information about the patient however does not generate a result as to whether the patient is suitable for active surveillance.
Control group
Active

Outcomes
Primary outcome [1] 337316 0
To examine if the use of a clinical support tool will increase the uptake in patients who choose active surveillance.
Timepoint [1] 337316 0
The trial will run for 36 months in total, commencing from when the first site has governance approval.
Primary outcome [2] 337317 0
To determine if the application of a clinical support tool will be able to identify patients who are appropriate for active surveillance
Timepoint [2] 337317 0
36 months from the start of the study commencement.
Secondary outcome [1] 431422 0
Rates of disease progression in patients who choose active surveillance.
Timepoint [1] 431422 0
Baseline thyroid ultrasound (US), then 6 monthly for first two years and annual thereafter. The timing of the six monthly ultrasounds will start based on six months from the initial ultrasound that made them eligible for the study, not the timing of the intervention.
Secondary outcome [2] 431423 0
Determine clinician acceptability of active surveillance as a management option for low risk thyroid cancer.
Timepoint [2] 431423 0
Baseline at clinician enrolment into the study and at completion of the study period.
Secondary outcome [3] 431424 0
Compare quality of life in patients who undergo active surveillance and those who undergo immediate surgery
Timepoint [3] 431424 0
Patients will complete this survey 12 months after enrolling into the trial.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in the study if all of the below are met:
• Age 18 or above
• Thyroid nodule 2cm or smaller
• Bethesda III, V or Bethesda VI result on FNA cytopathology

Clinicians will be eligible for inclusion if they are involved in the treatment of patients with thyroid cancer.


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from study if:
• Age <18
• Thyroid nodule >2cm in size
• Bethesda result other than BIII, BV or BVI
• If they are unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinicians will be block randomised to either the control or intervention tool through the use of an online website (Sealed Envelope). When a new clinician is enrolled into the study, study coordinators will use the website to have the clinician randomised to either the control or intervention tool.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/05/2024
Actual
Date of last participant enrolment
Anticipated
8/05/2027
Actual
Date of last data collection
Anticipated
8/05/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 315764 0
Hospital
Name [1] 315764 0
Department of Endocrinology, Royal North Shore Hospital
Country [1] 315764 0
Australia
Funding source category [2] 316049 0
Hospital
Name [2] 316049 0
Department of Radiology - In kind radiology support to review images
Country [2] 316049 0
Australia
Primary sponsor type
Hospital
Name
Department of Endocrinology, Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 317890 0
None
Name [1] 317890 0
Address [1] 317890 0
Country [1] 317890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314624 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314624 0
Ethics committee country [1] 314624 0
Australia
Date submitted for ethics approval [1] 314624 0
30/10/2023
Approval date [1] 314624 0
27/11/2023
Ethics approval number [1] 314624 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132202 0
Dr Matti Gild
Address 132202 0
Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales
Country 132202 0
Australia
Phone 132202 0
+61 2 9463 1680
Fax 132202 0
Email 132202 0
[email protected]
Contact person for public queries
Name 132203 0
Dr Eleanor White
Address 132203 0
Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales
Country 132203 0
Australia
Phone 132203 0
+61 2 9463 1680
Fax 132203 0
Email 132203 0
[email protected]
Contact person for scientific queries
Name 132204 0
Dr Eleanor White
Address 132204 0
Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales
Country 132204 0
Australia
Phone 132204 0
+61 2 9463 1680
Fax 132204 0
Email 132204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.