Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer (MAeSTro-SDM)

National Cancer Center (NCC)

Status: Not yet enrolling

Conditions: Papillary Thyroid Carcinoma; Thyroid Cancer

Treatments: Other: SDM protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06730893

2025-0008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

310 participants in 2 patient groups

SDM Group (Shared Decision-Making Group; Intervention Group)

Experimental group

Description:

* 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.

Treatment:

Other: SDM protocol

SC Group (Standard Care Group; Control Group)

No Intervention group

Description:

- Patients will receive standard medical care following current clinical practices without the SDM protocol.