Menu
Not yet recruiting NCT06730893

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

No phase Interventional Thyroid Cancer Papillary Thyroid Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SDM protocol.
Who it may be relevant to
Registry conditions: Thyroid Cancer, Papillary Thyroid Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Interventions

  • Other SDM protocol
    Card news and Videos related to general knowledge and treatment of low-risk thyroid cancer

Primary outcome measures

  • Decision Conflict Scale: DCS [Time frame: at enrollment]
Secondary outcome measures (6)
  • Decision Regret Scale: DRS [Time frame: at 6month, 12month after enrollment]
  • Shared Decision Making Questionnaire (SDM-Q-9) [Time frame: at enrollment, and 6month, 12month after enrollment]
  • Patients' Perceived involvement of Care Scale (PICS) [Time frame: at enrollment, and 6month, 12month after enrollment]
  • multifocal approach to sharing in shared decision making(Mappin'SDM) [Time frame: at enrollment, and 6month, 12month after enrollment]
  • Comparison of Quality of Life between the shared decision group and standard care group [Time frame: at enrollment, and 6month, 12month after enrollment]
  • Hospital Anxiety and Depression [Time frame: at enrollment, and 6month, 12month after enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

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 PMID 41589080

Identifiers

NCT: NCT06730893 · 2025-0008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗