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Thyroid CancerMAeSTro-SDMNCT06730893

Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer

A study testing SDM protocol in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by National Cancer Center, Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer, Papillary Thyroid Carcinoma
What is being tested?
SDM protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
No sites listed yet
Study dates
12 May 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years or older with a thyroid nodule of 1.0 cm or less confirmed as Bethesda category V (suspicious for PTC) or VI (PTC) based on cytopathological examination, or Bethesda category III (atypia of undetermined significance) with a confirmed BRAF V600E mutation.
  • Patients with no evidence of distant metastasis, cervical lymph node metastasis, recurrent laryngeal nerve invasion, or tracheal invasion. Additionally, no evidence of extrathyroidal extension (ETE) should be present, and the tumor must not belong to high-risk subtypes of PTC (e.g., diffuse sclerosing, columnar cell, or solid subtype).

Who cannot join

  • Patients who cannot undergo regular follow-up or are expected to have difficulties with follow-up.
  • Patients with indeterminate or benign findings on thyroid biopsy.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Eun Kyung Lee contact

+82-31-920-1743

eklee@ncc.re.kr

About this study

Official title: Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled Trial

This study is a multicenter cluster-randomized controlled trial conducted in Korea. A parallel, two-group cluster-randomized design will be used to test whether the Shared decision-making Group (SDM; intervention) is different from the Standard Care Group (SC; control).

Read the detailed description

The primary objective of this clinical trial is to evaluate whether the group provided with a decision support tool for treatment planning (Intervention; SDM group) demonstrates improved satisfaction with the decision-making process compared to the group receiving standard care (Control; SC group) among patients diagnosed with low-risk thyroid cancer who need to determine their treatment plan.

The data are collected from patients who are diagnosed with low-risk PTC and Twenty doctors with various experience of AS will participate in the study.

Being tested
SDM protocol
Keywords
Active surveillance, Shared decision making
Medical subject headings
Thyroid Neoplasms, Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDM protocolOther

    Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer

Study groups in NCT06730893
Study groupRoleWhat they receive
SDM Group (Shared Decision-Making Group; Intervention Group)Experimental* Patients will receive detailed information, including an information leaflet about treatment options. * Clinicians will guide patients through a structured SDM protocol before finalizing the treatment decision.
Receives: Other: SDM protocol
SC Group (Standard Care Group; Control Group)No intervention- Patients will receive standard medical care following current clinical practices without the SDM protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decision Conflict Scale: DCS

    which assesses an individual's perception and understanding of decision-making by 16 items. The scale is 5-point Likert scale from 0 (Strongly Agree) to 4 (Strongly Disagree), and scores are calculated through a) summed, b) divided by 16, and c) multiplied by 25, and range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

    Measured: at enrollment

Secondary outcomes (6)

  1. Decision Regret Scale: DRS

    measures distress and remorse after making a healthcare decision. Scale ranges from 1 (Strongly agree) to 5(Strongly Disagree). The final score, the items are summed and averaged. ranging from 0 (no regret) to 100 (high regret).

    Measured: at 6month, 12month after enrollment

  2. Shared Decision Making Questionnaire (SDM-Q-9)

    a nine-item questionnaire assessing the quality of SDM from both patient and clinician perspectives. Scale ranges from 1(completely disagree) to 6(completely agree). Higher scores are indicative of more SDM.

    Measured: at enrollment, and 6month, 12month after enrollment

  3. Patients' Perceived involvement of Care Scale (PICS)

    a 13-item questionnaire evaluating patient engagement in primary care [12]. It measures Clinician's information provision, patient's proactive information-seeking, and patient participation in treatment decisions (5-point Likert scale; 1 = Strongly Disagree, 5 = Strongly Agree). Higher scores indicate lower clinician control and greater patient involvement in decision-making.

    Measured: at enrollment, and 6month, 12month after enrollment

  4. multifocal approach to sharing in shared decision making(Mappin'SDM)

    that incorporates physician, patient, and observer perspectives during medical consultations. a 15-item tool adapted from the 12-item OPTION scale to evaluate observed patient involvement in decision-making [13]. Each item consists of behavioral and outcome components (a total of 30 items), rated by patients, clinicians, and observers (through real-time or via video review). Scale ranges from 0(not at all) to 5(absolutely true). High scores indicate high quality of decision-making communication across patient engagement.

    Measured: at enrollment, and 6month, 12month after enrollment

  5. Comparison of Quality of Life between the shared decision group and standard care group

    The Quality of Life - Thyroid (QOL-Thyroid) questionnaire was 30 items. These are assigned to four scales, each reflecting an aspect of QoL. Physical well-being is measured with two items and 13 questions, psychological well-being with 13 items and 22 questions, social concerns with eight items and 14 questions, and spiritual well-being with seven items and questions. Response options range from '0 = worst outcome' to '10 = best outcome' on an ordinal 11-point scale.

    Measured: at enrollment, and 6month, 12month after enrollment

  6. Hospital Anxiety and Depression

    a 14-item tool (7 for anxiety, 7 for depression), developed to measure hospital patients' levels of anxiety and depression. Each item is rated on a 0-3 scale, with total scores ranging from 0 to 21 per subscale. A cutoff score of 8 or higher indicates clinically significant symptoms, based on Korean validation studies.

    Measured: at enrollment, and 6month, 12month after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start12 May 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730893
Sponsor's protocol ID
2025-0008
Acronym
MAeSTro-SDM
Status last verified
Apr 2025
First submitted
9 Dec 2024
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee EK, Kim MJ, Hwangbo Y, Moon JH, Cho SW, Chai YJ, Choi JY, Jung YS, Lee KE, Chung EJ, Kim K, Kim SJ, Kim W, Kim YH, Lee YK, Jang J, Song YS, Yi KH, Yu HW, Moon S, Jung KY, Kim HJ, Ryu CH, Ryu J, Seok J, Kang SH, Lee S, Chu AJ, Lee CY, Lee JY, Lim H, Kim JH, Park SK, Park YJ. Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: Protocol of a Multicenter Cluster-Randomized Trial (MAeSTro-SDM). J Korean Med Sci. 2026 Jan 26;41(4):e58. doi: 10.3346/jkms.2026.41.e58.

    PubMed 41589080

Questions about this trial

What is this clinical trial studying?

A study testing SDM protocol in people with Thyroid Cancer and Papillary Thyroid Carcinoma, run by National Cancer Center, Korea.

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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eun Kyung Lee (+82-31-920-1743, eklee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decision Conflict Scale: DCS (time frame: at enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730893, which also lists 1 linked publication.

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 30 Apr 2025.

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