Clinical trial · Interventional
Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer
Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled Trial
NCT06730893CI-TRIAL-00089131MAeSTro-SDMnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Thyroid Carcinoma | Thyroid Gland Papillary Carcinoma | ALIAS | 0.90 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SDM protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SDM Group (Shared Decision-Making Group; Intervention 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.
- interventionNames
- Other: SDM protocol
- type
- NO_INTERVENTION
- label
- SC Group (Standard Care Group; Control Group)
- description
- \- Patients will receive standard medical care following current clinical practices without the SDM protocol.
Primary outcomes (1)
- measure
- Decision Conflict Scale: DCS
- timeFrame
- at enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLee 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. PMID 41589080