Shared Decision-Making for Determining Treatment Strategies in Low-Risk Thyroid Cancer: a Multicenter Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 主要终点
- Decision Conflict Scale: DCS
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Decision Conflict Scale: DCS
时间窗: at enrollment
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).
次要结局
- 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)
- Comparison of Quality of Life between the shared decision group and standard care group(at enrollment, and 6month, 12month after enrollment)
- multifocal approach to sharing in shared decision making(Mappin'SDM)(at enrollment, and 6month, 12month after enrollment)
- Hospital Anxiety and Depression(at enrollment, and 6month, 12month after enrollment)