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

NCT06730893 | Not Yet Recruiting

• 1 other identifier: 2025-0008
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Thyroid Cancer; Papillary Thyroid Carcinoma

Keywords

Active surveillance; Shared decision making

Outcome Measures

Primary Outcomes (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).

  at enrollment

Secondary Outcomes (6)

• Decision Regret Scale: DRS

  at 6month, 12month after enrollment

• Shared Decision Making Questionnaire (SDM-Q-9)

  at enrollment, and 6month, 12month after enrollment

• Patients' Perceived involvement of Care Scale (PICS)

  at enrollment, and 6month, 12month after enrollment

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

  at enrollment, and 6month, 12month after enrollment

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

  at enrollment, and 6month, 12month after enrollment

Study Arms (2)

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.

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.

Interventions

SDM protocol OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Nowon Eulji Medical Center: collaborator
• Hanyang University: collaborator

Related Publications (1)

• 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.

  PMID: 41589080 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Young Joo Park

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Eun Kyung Lee

  National Cancer Center

  PRINCIPAL INVESTIGATOR

• Min Joo Kim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Young Shin Song

  SMC-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

• Kyong Yeun Jung

  Nowon Eulji Medical Center

  PRINCIPAL INVESTIGATOR

• Shin Je Moon

  Hanyang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Kyung Lee

CONTACT

+82-31-920-1743; eklee@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: May 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share