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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Thyroid Cancer

Condition category

Condition code

Cancer

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]

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]

To examine if the use of a clinical support tool will increase the uptake in patients who choose active surveillance.

Timepoint [1]

The trial will run for 36 months in total, commencing from when the first site has governance approval.

Primary outcome [2]

To determine if the application of a clinical support tool will be able to identify patients who are appropriate for active surveillance

Assessment method [2]

We will monitor rates of disease progression in the group who choose active surveillance. This will be determined through follow up ultrasound data which will be obtained via the medical records. The reference standard will be comparing rates of disease progression in the group who choose active surveillance (who are deemed appropriate by the tool) with that of published literature.

Citations -
1. Oda, H., Miyauchi, A., Ito, Y., Yoshioka, K., Nakayama, A., Sasai, H., Masuoka, H., Yabuta, T., Fukushima, M., Higashiyama, T., Kihara, M., Kobayashi, K., & Miya, A. (2016). Incidences of Unfavorable Events in the Management of Low-Risk Papillary Microcarcinoma of the Thyroid by Active Surveillance Versus Immediate Surgery. Thyroid, 26(1), 150-155. https://doi.org/10.1089/thy.2015.0313
2. Ito, Y., Miyauchi, A., Inoue, H., Fukushima, M., Kihara, M., Higashiyama, T., Tomoda, C., Takamura, Y., Kobayashi, K., & Miya, A. (2010). An observational trial for papillary thyroid microcarcinoma in Japanese patients. World J Surg, 34(1), 28-35. https://doi.org/10.1007/s00268-009-0303-0
3. Tuttle, R. M., Fagin, J., Minkowitz, G., Wong, R., Roman, B., Patel, S., Untch, B., Ganly, I., Shaha, A., Shah, J., Li, D., Bach, A., Girshman, J., Lin, O., Cohen, M., Cohen, J. M., Cracchiolo, J., Ghossein, R., Sabra, M., . . . Morris, L. (2022). Active Surveillance of Papillary Thyroid Cancer: Frequency and Time Course of the Six Most Common Tumor Volume Kinetic Patterns. Thyroid, 32(11), 1337-1345. https://doi.org/10.1089/thy.2022.0325
4. Sakai, T., Sugitani, I., Ebina, A., Fukuoka, O., Toda, K., Mitani, H., & Yamada, K. (2019). Active Surveillance for T1bN0M0 Papillary Thyroid Carcinoma. Thyroid, 29(1), 59-63. https://doi.org/10.1089/thy.2018.0462
5. Ho, A. S., Kim, S., Zalt, C., Melany, M. L., Chen, I. E., Vasquez, J., Mallen-St Clair, J., Chen, M. M., Vasquez, M., Fan, X., van Deen, W. K., Haile, R. W., Daskivich, T. J., Zumsteg, Z. S., Braunstein, G. D., & Sacks, W. L. (2022). Expanded Parameters in Active Surveillance for Low-risk Papillary Thyroid Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol, 8(11), 1588-1596. https://doi.org/10.1001/jamaoncol.2022.3875

Timepoint [2]

36 months from the start of the study commencement.

Secondary outcome [1]

Rates of disease progression in patients who choose active surveillance.

Timepoint [1]

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]

Determine clinician acceptability of active surveillance as a management option for low risk thyroid cancer.

Timepoint [2]

Baseline at clinician enrolment into the study and at completion of the study period.

Secondary outcome [3]

Compare quality of life in patients who undergo active surveillance and those who undergo immediate surgery

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Endocrinology, Royal North Shore Hospital

Address [1]

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Department of Radiology - In kind radiology support to review images

Address [2]

Country [2]

Australia

Primary sponsor type

Hospital

Name

Department of Endocrinology, Royal North Shore Hospital

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2023

Approval date [1]

27/11/2023

Ethics approval number [1]

Summary

Brief summary

Brief description of the study purpose:
This study looks at a web based clinical decision support tool, designed to assist clinicians in deciding whether their patient with low risk thyroid cancer is suitable for active surveillance (watch and wait approach).

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with Low Risk Thyroid Cancer. Clinicians who are involved in the management of patients with thyroid cancer will also be eligible to participate and provide their feedback on the web-based clinical support tool.

Study details
Clinicians will be randomly allocated by a randomisation table created by computer software to one of two groups. Clinicians allocated to the first group (intervention) will receive a link to a clinical decision support tool, where they will be able to use this tool to help determine if their patient with thyroid cancer is suitable for active surveillance. They will discuss this result with their patient and then together the patient and clinician will decide between active surveillance or surgery. 
Clinicians allocated to the second group (control) will receive a link to an online tool that will not generate a result of whether their patient with thyroid cancer is suitable to undergo active surveillance, but will instead provide information about the outcomes of active surveillance and surgery, They will discuss this with their patient and then together the patient and clinician will decide between active surveillance or surgery. 
Patients will choose either active surveillance or surgery after discussion with their clinician and all patients will be followed over time to see whether they have evidence of cancer progression. Quality of life in all patients will be assessed via a survey.
It is hoped this research will determine whether use of web-based clinical support tool has a positive impact on how clinicians discuss the management options for people with low risk thyroid cancer.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Matti Gild

Address

Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales

Country

Australia

Phone

+61 2 9463 1680

Fax

[email protected]

Contact person for public queries

Name

Dr Eleanor White

Address

Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales

Country

Australia

Phone

+61 2 9463 1680

Fax

[email protected]

Contact person for scientific queries

Name

Dr Eleanor White

Address

Department of Endocrinology, Royal North Shore Hospital, Reserve Road, St Leonards, 2065, New South Wales

Country

Australia

Phone

+61 2 9463 1680

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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